Trial Outcomes & Findings for TSolution One® Total Knee Arthroplasty (NCT NCT03017261)
NCT ID: NCT03017261
Last Updated: 2020-06-04
Results Overview
Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
3 months follow-up
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
TSolution One®
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
6 Week Follow up
STARTED
|
115
|
|
6 Week Follow up
COMPLETED
|
115
|
|
6 Week Follow up
NOT COMPLETED
|
0
|
|
3 Month Follow up
STARTED
|
115
|
|
3 Month Follow up
COMPLETED
|
115
|
|
3 Month Follow up
NOT COMPLETED
|
0
|
|
6 Month Follow up
STARTED
|
115
|
|
6 Month Follow up
COMPLETED
|
106
|
|
6 Month Follow up
NOT COMPLETED
|
9
|
|
12 Month Follow up
STARTED
|
106
|
|
12 Month Follow up
COMPLETED
|
59
|
|
12 Month Follow up
NOT COMPLETED
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TSolution One® Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Age, Continuous
|
65.91 years
STANDARD_DEVIATION 8.28 • n=99 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 months follow-upPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.
Outcome measures
| Measure |
TSolution One®
n=107 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
|
11.2 percentage of patients
Interval 6.3 to 18.2
|
PRIMARY outcome
Timeframe: Up to 12 months follow-upPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events
Outcome measures
| Measure |
TSolution One®
n=107 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months follow-upPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events.
Outcome measures
| Measure |
TSolution One®
n=107 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months follow-upPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).
Outcome measures
| Measure |
TSolution One®
n=107 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Bleeding Complications
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in (KSS) Knee Society Objective Score From Baseline
|
39.1 Units on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsThe computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=114 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Objective Score From Baseline
|
44.1 Units on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsThe computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=104 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Objective Score From Baseline
|
46.4 Units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsThe computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=58 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Objective Score From Baseline
|
48.2 Units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Satisfaction Score From Baseline
|
12.3 Units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsThe computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Satisfaction Score From Baseline
|
16.2 Units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsThe computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=106 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Satisfaction Score From Baseline
|
18.1 Units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsThe computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=59 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Satisfaction Score From Baseline
|
20.2 Units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Functional Score From Baseline
|
13.2 Units on a scale
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsThe computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Functional Score From Baseline
|
25.2 Units on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsThe computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=106 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Functional Score From Baseline
|
34.2 Units on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsThe computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=59 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in Knee Society Functional Score From Baseline
|
42.3 Units on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: BaselinePatient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Pre-operative (KSS) Knee Society Patient Expectation Score
|
14.5 Units on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 6 WeeksPatient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Post-operative (KSS) Knee Society Patient Expectation Score
|
9.8 Units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 3 MonthsPatient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Post-operative (KSS) Knee Society Patient Expectation Score
|
10.1 Units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 MonthsPatient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
Outcome measures
| Measure |
TSolution One®
n=106 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Post-operative (KSS) Knee Society Patient Expectation Score
|
10.3 Units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 MonthsPatient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
Outcome measures
| Measure |
TSolution One®
n=59 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Post-operative (KSS) Knee Society Patient Expectation Score
|
11.3 Units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
|
4.6 Units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
|
10.6 Units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=106 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
|
13.3 Units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=59 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
|
15.9 Units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
|
-2.0 Units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
|
0.4 Units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=106 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
|
1.4 Units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsThe computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
Outcome measures
| Measure |
TSolution One®
n=59 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
|
2.9 Units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsComparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
|
.35 Angle
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsComparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.
Outcome measures
| Measure |
TSolution One®
n=115 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
|
-0.93 Angle
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthsComparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery.
Outcome measures
| Measure |
TSolution One®
n=114 Participants
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Tibial Slope Change From Pre-op Plan
|
-0.01 Angle
Standard Deviation 1.53
|
Adverse Events
TSolution One®
Serious events: 12 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TSolution One®
n=115 participants at risk
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Stiffness of the joint
|
2.6%
3/115 • Number of events 3 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Cardiac disorders
Congestive Heart Failure
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Non-malignant asbestosis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Finger Fracture
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Renal and urinary disorders
Phimosis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Gastrointestinal disorders
Proctocolitis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Dehydration
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
Other adverse events
| Measure |
TSolution One®
n=115 participants at risk
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Anal Fissure
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Cardiac disorders
Arrhythmia
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Infections and infestations
Bladder Infection
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Vascular disorders
Bleeding, unrelated to surgical site/procedure
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Delayed Wound Healing
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Infections and infestations
Dental Infection
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Dental Pain
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Breathing
|
0.87%
1/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Edema
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Effusion
|
3.5%
4/115 • Number of events 5 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Blood and lymphatic system disorders
Exacerbation of anemia
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Injury, poisoning and procedural complications
Fall
|
3.5%
4/115 • Number of events 4 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Fatigue
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Psychiatric disorders
Generalized anxiety disorder
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Index knee pain
|
2.6%
3/115 • Number of events 3 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Injury, poisoning and procedural complications
Index knee pain
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Insect bite
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Nasal polyps
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Injury, poisoning and procedural complications
MCL Injury
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Psychiatric disorders
Kidney Stone
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Gastrointestinal disorders
Nausea
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Non-index knee pain
|
2.6%
3/115 • Number of events 3 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Ear and labyrinth disorders
Otitis media
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Skin and subcutaneous tissue disorders
Pressure sores
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Immune system disorders
Rheumatoid Arthritis
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Injury, poisoning and procedural complications
Retained device pins
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
General disorders
Seroma
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Infections and infestations
Systemic Infection
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Infections and infestations
Surgical Incision Infection
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
2/115 • Number of events 2 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Thigh pain
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Ear and labyrinth disorders
Temporary hearing loss
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Infections and infestations
Toe fungus
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Umbilical hernia
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Nervous system disorders
Worsening of Parkinson's Disease
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Renal and urinary disorders
Urinary tract infection
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
|
|
Musculoskeletal and connective tissue disorders
Pain (other musculoskeletal)
|
0.87%
1/115 • Number of events 1 • 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must submit proposed publications to Sponsor for review per contract timelines. Hospital \& PI shall: * not publish the Hospital's and PI's results until a multi-center publication is released; however, if a multi-center publication is not released within 1 year after the study, Hospital \& PI may publish the results of their activities. * keep all unpublished data \& results confidential and not disclose such in greater detail than disclosed in any publications, presentations or disclosures.
- Publication restrictions are in place
Restriction type: OTHER