Trial Outcomes & Findings for Verifying the Effectiveness of the NUsurface® System (NCT NCT02108496)
NCT ID: NCT02108496
Last Updated: 2026-07-28
Results Overview
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
337 participants
Primary outcome timeframe
2 years
Results posted on
2026-07-28
Participant Flow
Of the 337 assessed for eligibility there were 187 were excluded prior to Treatment Allocation ( 165 - Not Meeting Inclusion Criteria; 22 - Declined to Participate ) and 150 proceeded to Randomization.
Participant milestones
| Measure |
Control
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
Investigational
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
|---|---|---|
|
Treatment Allocation/Randomization
STARTED
|
73
|
77
|
|
Treatment Allocation/Randomization
COMPLETED
|
66
|
61
|
|
Treatment Allocation/Randomization
NOT COMPLETED
|
7
|
16
|
|
1.5 Month Follow-Up
STARTED
|
66
|
61
|
|
1.5 Month Follow-Up
COMPLETED
|
64
|
61
|
|
1.5 Month Follow-Up
NOT COMPLETED
|
2
|
0
|
|
3 Month Follow-Up
STARTED
|
64
|
61
|
|
3 Month Follow-Up
COMPLETED
|
62
|
61
|
|
3 Month Follow-Up
NOT COMPLETED
|
2
|
0
|
|
6 Month Follow-Up
STARTED
|
62
|
61
|
|
6 Month Follow-Up
COMPLETED
|
55
|
61
|
|
6 Month Follow-Up
NOT COMPLETED
|
7
|
0
|
|
12 Month Follow-Up
STARTED
|
55
|
61
|
|
12 Month Follow-Up
COMPLETED
|
48
|
58
|
|
12 Month Follow-Up
NOT COMPLETED
|
7
|
3
|
|
24 Month Follow-Up
STARTED
|
48
|
58
|
|
24 Month Follow-Up
COMPLETED
|
43
|
53
|
|
24 Month Follow-Up
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Control
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
Investigational
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
|---|---|---|
|
Treatment Allocation/Randomization
Withdrew Prior to Start of Treatment
|
7
|
8
|
|
Treatment Allocation/Randomization
Excluded lntraoperatively (Bailout)
|
0
|
8
|
|
1.5 Month Follow-Up
Lost to Follow-up
|
1
|
0
|
|
1.5 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
|
3 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
|
3 Month Follow-Up
Device Removal or Discontinued Non-Surgical Care
|
1
|
0
|
|
6 Month Follow-Up
Lost to Follow-up
|
2
|
0
|
|
6 Month Follow-Up
Withdrawal by Subject
|
2
|
0
|
|
6 Month Follow-Up
Device Removal or Discontinued Non-Surgical Care
|
3
|
0
|
|
12 Month Follow-Up
Lost to Follow-up
|
2
|
0
|
|
12 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
|
12 Month Follow-Up
Device Removal or Discontinued Non-Surgical Care
|
4
|
3
|
|
24 Month Follow-Up
Lost to Follow-up
|
2
|
1
|
|
24 Month Follow-Up
Withdrawal by Subject
|
2
|
0
|
|
24 Month Follow-Up
Device Removal or Discontinued Non-Surgical Care
|
1
|
3
|
|
24 Month Follow-Up
Missed 2-Yr Follow-Up
|
0
|
1
|
Baseline Characteristics
Verifying the Effectiveness of the NUsurface® System
Baseline characteristics by cohort
| Measure |
Control
n=66 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
Investigational
n=61 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.82 years
STANDARD_DEVIATION 10.27 • n=20 Participants
|
50.95 years
STANDARD_DEVIATION 11.20 • n=20 Participants
|
50.36 years
STANDARD_DEVIATION 10.70 • n=40 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
96 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
127 Participants
n=40 Participants
|
|
Body Mass Index
|
26.83 kg/m^2
STANDARD_DEVIATION 3.64 • n=20 Participants
|
26.79 kg/m^2
STANDARD_DEVIATION 3.24 • n=20 Participants
|
26.81 kg/m^2
STANDARD_DEVIATION 3.44 • n=40 Participants
|
|
KOOS Subscore - Pain
|
54.17 units on a scale
STANDARD_DEVIATION 15.57 • n=20 Participants
|
52.14 units on a scale
STANDARD_DEVIATION 11.16 • n=20 Participants
|
53.19 units on a scale
STANDARD_DEVIATION 13.62 • n=40 Participants
|
|
KOOS Subscore - Symptoms
|
62.55 units on a scale
STANDARD_DEVIATION 16.54 • n=20 Participants
|
59.39 units on a scale
STANDARD_DEVIATION 15.33 • n=20 Participants
|
61.03 units on a scale
STANDARD_DEVIATION 15.99 • n=40 Participants
|
|
KOOS Subscore - Activities of Daily Living
|
65.26 units on a scale
STANDARD_DEVIATION 19.88 • n=20 Participants
|
63.43 units on a scale
STANDARD_DEVIATION 16.01 • n=20 Participants
|
64.38 units on a scale
STANDARD_DEVIATION 18.08 • n=40 Participants
|
|
KOOS Subscore - Sports and Recreation
|
39.28 units on a scale
STANDARD_DEVIATION 21.65 • n=20 Participants
|
35.49 units on a scale
STANDARD_DEVIATION 22.24 • n=20 Participants
|
37.46 units on a scale
STANDARD_DEVIATION 21.93 • n=40 Participants
|
|
KOOS Subscore - Quality of Life
|
30.02 units on a scale
STANDARD_DEVIATION 13.53 • n=20 Participants
|
27.56 units on a scale
STANDARD_DEVIATION 16.90 • n=20 Participants
|
28.84 units on a scale
STANDARD_DEVIATION 15.23 • n=40 Participants
|
|
KOOS Score Overall
|
50.26 units on a scale
STANDARD_DEVIATION 14.29 • n=20 Participants
|
47.60 units on a scale
STANDARD_DEVIATION 12.62 • n=20 Participants
|
48.98 units on a scale
STANDARD_DEVIATION 13.53 • n=40 Participants
|
|
Visual Analog Scale (VAS) Pain Score
|
50.83 units on a scale
STANDARD_DEVIATION 23.70 • n=20 Participants
|
53.19 units on a scale
STANDARD_DEVIATION 20.48 • n=20 Participants
|
51.97 units on a scale
STANDARD_DEVIATION 22.15 • n=40 Participants
|
|
WOMET Normalized Score
|
39.05 units on a scale
STANDARD_DEVIATION 16.58 • n=20 Participants
|
36.33 units on a scale
STANDARD_DEVIATION 16.16 • n=20 Participants
|
37.74 units on a scale
STANDARD_DEVIATION 16.37 • n=40 Participants
|
|
IKDC Subjective Knee Assessment
|
45.43 units on a scale
STANDARD_DEVIATION 13.97 • n=20 Participants
|
42.35 units on a scale
STANDARD_DEVIATION 13.21 • n=20 Participants
|
43.96 units on a scale
STANDARD_DEVIATION 13.65 • n=40 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis of Overall Success is based on the modified intention-to-treat (MITT) populations, which is defined as subjects who received the allocated treatment after randomization. Subjects who were Lost to Follow-Up and who Withdrew Consent during the course of the 24 Months are not included in the Overall Success analysis.
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Outcome measures
| Measure |
Investigational
n=61 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=66 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
Overall Success Composite Endpoint
Overall Success
|
26 Participants
|
12 Participants
|
|
Overall Success Composite Endpoint
Overall Failure
|
34 Participants
|
40 Participants
|
|
Overall Success Composite Endpoint
Lost To Follow-Up
|
1 Participants
|
7 Participants
|
|
Overall Success Composite Endpoint
Withdrawn Consent
|
0 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 2 YearsThe automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
Outcome measures
| Measure |
Investigational
n=61 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=66 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
Automatic Study Failure
Withdrew Consent
|
0 Participants
|
7 Participants
|
|
Automatic Study Failure
Did Not Have Automatic Study Failure
|
46 Participants
|
43 Participants
|
|
Automatic Study Failure
Automatic Study Failure
|
14 Participants
|
9 Participants
|
|
Automatic Study Failure
Lost to Follow-Up
|
1 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: There were 31 out of 127 subjects (23 on control and 8 on NUsurface) that did not have 24 Month KOOS scores so were removed from KOOS Success analysis as they were not considered viable.
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
Outcome measures
| Measure |
Investigational
n=61 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=66 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Success
Withdrew Consent
|
0 Participants
|
7 Participants
|
|
KOOS Success
Stopped Treatment per Automatic Study Failure
|
7 Participants
|
9 Participants
|
|
KOOS Success
KOOS Success
|
33 Participants
|
12 Participants
|
|
KOOS Success
KOOS Failure
|
20 Participants
|
31 Participants
|
|
KOOS Success
Lost to Follow-Up
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 YearsThe subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Subscale - Pain
|
78.57 score on a scale
Standard Deviation 73.30
|
68.60 score on a scale
Standard Deviation 63.26
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Excludes subjects that are Lost to Follow-Up prior to 24 Months or who Withdrew Consent prior to 24 Months.
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Subscale - Symptoms
|
75.61 score on a scale
Standard Deviation 18.66
|
70.60 score on a scale
Standard Deviation 18.85
|
SECONDARY outcome
Timeframe: 2 YearsThe subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Subscale - ADL
|
87.50 score on a scale
Standard Deviation 83.31
|
78.36 score on a scale
Standard Deviation 73.20
|
SECONDARY outcome
Timeframe: 2 YearsThe subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Subscale - Sports and Recreation
|
64.69 score on a scale
Standard Deviation 56.78
|
58.02 score on a scale
Standard Deviation 50.46
|
SECONDARY outcome
Timeframe: 2 YearsThe subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Subscale - Quality of Life
|
60.61 score on a scale
Standard Deviation 53.71
|
50.15 score on a scale
Standard Deviation 43.83
|
SECONDARY outcome
Timeframe: 2 YearsAverage of all 5 KOOS Subscales
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
KOOS Overall Score
|
73.39 score on a scale
Standard Deviation 68.07
|
65.15 score on a scale
Standard Deviation 60.04
|
SECONDARY outcome
Timeframe: 2 YearsVisual Analog Scale (VAS) Pain Score is scored from the best lowest score of 0 to the worse pain score of 100.
Outcome measures
| Measure |
Investigational
n=52 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
VAS Pain Score
|
16.83 units on a scale
Standard Deviation 10.99
|
29.51 units on a scale
Standard Deviation 22.02
|
SECONDARY outcome
Timeframe: 2 YearsWestern Ontario Meniscal Evaluation Tool is a disease specific quality of life measurement tool for patients with meniscal lesions. Each question is scored from 0 (most favorable condition) to 100 (least favorable condition). When combining all scores from the 16 possible questions, the best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. The score may be reported as a total overall score, as a total score for each domain, or as a percentage of normal by subtracting the total score from 1600, dividing by 1600, and multiplying by 100. If the normalized score is used, then the least favorable condition is 0 and the most favorable condition is 100.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
WOMET Normalized Score
|
72.23 score on a scale
Standard Deviation 65.59
|
57.29 score on a scale
Standard Deviation 50.19
|
SECONDARY outcome
Timeframe: 2 YearsThe International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a patient-reported measure of knee symptoms, function, and sports activity. The total score ranges from 0 to 100, where 0 represents the worst symptoms/function and 100 represents the best; higher scores indicate a better outcome. The score is calculated by summing responses to the 18 items, then transforming to a 0-100 scale using: \[(raw score - lowest possible raw score) / range of raw score\] × 100. No subscale scores are reported.
Outcome measures
| Measure |
Investigational
n=53 Participants
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=43 Participants
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
IKDC Subjective Knee Score
|
67.69 score on a scale
Standard Deviation 62.12
|
56.48 score on a scale
Standard Deviation 51.85
|
Adverse Events
Investigational
Serious events: 29 serious events
Other events: 57 other events
Deaths: 0 deaths
Control
Serious events: 12 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational
n=61 participants at risk
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=66 participants at risk
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Lateral meniscal tear
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Medial meniscal tear
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Non-specific knee pain
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
4.5%
3/66 • Number of events 3 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Tibial-femoral Functional Instability
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Cardiac disorders
Pulmonary Valve Disease
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Eye disorders
Cataract
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 2 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Gastrointestinal disorders
Appendicitis
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Gastrointestinal disorders
Non-specific gastrointestinal illness / disorder
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Anterior dislocation (initial)
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Cervical disc herniation
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Hallux rigidus
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Ipsilateral) Medial meniscal tear
|
4.9%
3/61 • Number of events 3 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
Scapholunate dissociation
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Renal and urinary disorders
Non-specific GU illness / disorder
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis / lower respiratory tract infection
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Cardiac disorders
(SADE) Deep vein thrombosis
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Infections and infestations
(SADE) Infection
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
Removal: Damage and/or Dislocation
|
6.6%
4/61 • Number of events 4 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
Exchange: Damage and/or Dislocation
|
9.8%
6/61 • Number of events 6 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
Removal: Rotation
|
3.3%
2/61 • Number of events 2 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
Exchange: Rotation
|
3.3%
2/61 • Number of events 2 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
Reoperation: Dislocation or Rotation
|
3.3%
2/61 • Number of events 2 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Surgical and medical procedures
(SADE) Adhesions/Cysts/Synovitis
|
8.2%
5/61 • Number of events 5 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Knee synovitis
|
0.00%
0/61 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
1.5%
1/66 • Number of events 1 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
Other adverse events
| Measure |
Investigational
n=61 participants at risk
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
NUsurface® Meniscus Implant: The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
|
Control
n=66 participants at risk
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
NSAID's and Non-surgical Treatment Options: Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids: Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA): Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
|
|---|---|---|
|
Product Issues
(Index Knee) Limited Rom
|
6.6%
4/61 • Number of events 4 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
(Index Knee) Mechanical Symptoms
|
9.8%
6/61 • Number of events 6 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Product Issues
(Index Knee) Noise
|
14.8%
9/61 • Number of events 10 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Nervous system disorders
Sciatica
|
6.6%
4/61 • Number of events 4 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
0.00%
0/66 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Effusion
|
41.0%
25/61 • Number of events 33 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
3.0%
2/66 • Number of events 3 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
|
Musculoskeletal and connective tissue disorders
(Index Knee) Non-specific knee pain
|
14.8%
9/61 • Number of events 10 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
6.1%
4/66 • Number of events 4 • Adverse Events were collected over 24 Months
As a medical device investigation the VENUS study encompasses the ClinicalTrial.Gov definitions and extends them to include ADE (Adverse Device Effect) and SADE (Serious Adverse Device Effect). See ISO 14155 categories of Adverse Events. In almost all cases of SADE, the criteria that warranted the term "Serious" was the office procedure that required general anesthesia and a scope \& incision for revision.
|
Additional Information
Vice President of Regulatory and Clinical Affairs
Active Implants, LLC
Phone: 901.762.0352
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place