Trial Outcomes & Findings for Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (NCT NCT02016300)
NCT ID: NCT02016300
Last Updated: 2019-06-27
Results Overview
KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
COMPLETED
NA
24 participants
2 years
2019-06-27
Participant Flow
Participant milestones
| Measure |
Unloader Bracing
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Unloader Bracing
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
Baseline characteristics by cohort
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
40.0 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
76.8 units on a scale
STANDARD_DEVIATION 18.9 • n=99 Participants
|
79.6 units on a scale
STANDARD_DEVIATION 16.1 • n=107 Participants
|
78.0 units on a scale
STANDARD_DEVIATION 17.4 • n=206 Participants
|
|
Tegner Score
|
2.2 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.9 • n=107 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
SF-12 Score
|
28.8 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 2.4 • n=107 Participants
|
28.8 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Lysholm Score
|
63.6 units on a scale
STANDARD_DEVIATION 24.7 • n=99 Participants
|
51.3 units on a scale
STANDARD_DEVIATION 24.7 • n=107 Participants
|
58.3 units on a scale
STANDARD_DEVIATION 24.9 • n=206 Participants
|
|
T2 Relaxation time
|
31.4 milliseconds (ms)
STANDARD_DEVIATION 38.1 • n=99 Participants
|
42.8 milliseconds (ms)
STANDARD_DEVIATION 96.8 • n=107 Participants
|
36.5 milliseconds (ms)
STANDARD_DEVIATION 68.3 • n=206 Participants
|
|
Cartilage Volume
|
-6.5 mm^3
STANDARD_DEVIATION 36.3 • n=99 Participants
|
-6.3 mm^3
STANDARD_DEVIATION 46.3 • n=107 Participants
|
-6.4 mm^3
STANDARD_DEVIATION 39.8 • n=206 Participants
|
|
Cartilage Thickness
|
-0.1 mm
STANDARD_DEVIATION 0.3 • n=99 Participants
|
-0.2 mm
STANDARD_DEVIATION 0.4 • n=107 Participants
|
-0.1 mm
STANDARD_DEVIATION 0.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Change at month 6
|
12.0 units on a scale
Standard Deviation 12.2
|
4.1 units on a scale
Standard Deviation 12.2
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Change at month 12
|
19.1 units on a scale
Standard Deviation 16.9
|
8.1 units on a scale
Standard Deviation 11.5
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Change at month 24
|
17.8 units on a scale
Standard Deviation 16.7
|
4.6 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score \>6 can only be achieved if the person participates in recreational or competitive sport.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in Tegner Score (Clinical Outcome)
Change at month 6
|
1.7 units on a scale
Standard Deviation 1.2
|
0.9 units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Tegner Score (Clinical Outcome)
Change at month 12
|
2.7 units on a scale
Standard Deviation 1.1
|
1.9 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Tegner Score (Clinical Outcome)
Change at month 24
|
2.3 units on a scale
Standard Deviation 1.9
|
1.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Change at month 6
|
2.2 units on a scale
Standard Deviation 3.0
|
2.9 units on a scale
Standard Deviation 5.5
|
|
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Change at month 12
|
2.4 units on a scale
Standard Deviation 4.1
|
2.3 units on a scale
Standard Deviation 3.0
|
|
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Change at month 24
|
0.8 units on a scale
Standard Deviation 5.1
|
2.1 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in Lysholm Score (Clinical Outcome)
Change at month 6
|
14.3 units on a scale
Standard Deviation 16.2
|
11.1 units on a scale
Standard Deviation 23.1
|
|
Change From Baseline in Lysholm Score (Clinical Outcome)
Change at month 12
|
25.7 units on a scale
Standard Deviation 33.9
|
20.3 units on a scale
Standard Deviation 21.7
|
|
Change From Baseline in Lysholm Score (Clinical Outcome)
Change at month 24
|
20.3 units on a scale
Standard Deviation 20.5
|
18.8 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Change at month 12
|
-24.5 millisecond (ms)
Standard Deviation 25.3
|
-36.2 millisecond (ms)
Standard Deviation 73.8
|
|
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Change at month 24
|
-25.1 millisecond (ms)
Standard Deviation 25.1
|
-17.6 millisecond (ms)
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Change at month 12
|
31.4 mm^3
Standard Deviation 31.8
|
-2.1 mm^3
Standard Deviation 37.5
|
|
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Change at month 24
|
49.2 mm^3
Standard Deviation 35.8
|
17.8 mm^3
Standard Deviation 52.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed the protocol were included in the analysis.
Outcome measures
| Measure |
Unloader Bracing
n=12 Participants
This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
Non-Bracing Arm
n=9 Participants
This group was randomly selected and assigned to wear no brace post-operatively.
|
|---|---|---|
|
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Change at month 12
|
0.3 mm
Standard Deviation 0.3
|
-0.2 mm
Standard Deviation 0.4
|
|
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Change at month 24
|
0.3 mm
Standard Deviation 0.3
|
0.1 mm
Standard Deviation 0.2
|
Adverse Events
Unloader Bracing
Non-Bracing Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place