Cartilage Loss, Microfracture
Conditions
Keywords
cartilage, microfracture, knee, bracing
Brief summary
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes. The surgery performed will be the same for all patients The length of follow up and schedule of post-operative MRI will be the same for all patients. The only difference in groups will be presence of absence of brace wear.
Detailed description
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes. The surgery performed will be the same for all patients The length of follow up and schedule of post-operative MRI will be the same for all patients. The only difference in groups will be presence of absence of brace wear.
Interventions
DEVICEUnloader Bracing
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
DEVICENon-Bracing
Microfracture performed with no post-operative unloader bracing
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* isolated chondral defect of medial or lateral femoral condyle 2cm squared or less * age 15-40 * neutral knee alignment
Exclusion criteria
* prior cartilage procedures performed in the same knee * other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | 2 years | 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. |
| Change From Baseline in Lysholm Score (Clinical Outcome) | 2 years | 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. |
| Change From Baseline in Tegner Score (Clinical Outcome) | 2 years | 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. |
| Change From Baseline in Cartilage Volume (Radiographic Outcome) | 2 years | — |
| Change From Baseline in Cartilage Thickness (Radiographic Outcome) | 2 years | — |
| Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | 2 years | T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unloader Bracing This group was randomly selected and assigned to wear an unloader brace post-operatively during the study period. | 12 |
| Non-Bracing Arm This group was randomly selected and assigned to wear no brace post-operatively. | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Unloader Bracing | Non-Bracing Arm | Total |
|---|---|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 8.5 | 39.6 years STANDARD_DEVIATION 10.2 | 40.0 years STANDARD_DEVIATION 9 |
| Cartilage Thickness | -0.1 mm STANDARD_DEVIATION 0.3 | -0.2 mm STANDARD_DEVIATION 0.4 | -0.1 mm STANDARD_DEVIATION 0.3 |
| Cartilage Volume | -6.5 mm^3 STANDARD_DEVIATION 36.3 | -6.3 mm^3 STANDARD_DEVIATION 46.3 | -6.4 mm^3 STANDARD_DEVIATION 39.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 76.8 units on a scale STANDARD_DEVIATION 18.9 | 79.6 units on a scale STANDARD_DEVIATION 16.1 | 78.0 units on a scale STANDARD_DEVIATION 17.4 |
| Lysholm Score | 63.6 units on a scale STANDARD_DEVIATION 24.7 | 51.3 units on a scale STANDARD_DEVIATION 24.7 | 58.3 units on a scale STANDARD_DEVIATION 24.9 |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
| SF-12 Score | 28.8 units on a scale STANDARD_DEVIATION 2.9 | 28.9 units on a scale STANDARD_DEVIATION 2.4 | 28.8 units on a scale STANDARD_DEVIATION 2.6 |
| T2 Relaxation time | 31.4 milliseconds (ms) STANDARD_DEVIATION 38.1 | 42.8 milliseconds (ms) STANDARD_DEVIATION 96.8 | 36.5 milliseconds (ms) STANDARD_DEVIATION 68.3 |
| Tegner Score | 2.2 units on a scale STANDARD_DEVIATION 1.3 | 2.0 units on a scale STANDARD_DEVIATION 1.9 | 2.1 units on a scale STANDARD_DEVIATION 1.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
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.
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 6 | 12.0 units on a scale | Standard Deviation 12.2 |
| Unloader Bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 12 | 19.1 units on a scale | Standard Deviation 16.9 |
| Unloader Bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 24 | 17.8 units on a scale | Standard Deviation 16.7 |
| Non-Bracing Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 6 | 4.1 units on a scale | Standard Deviation 12.2 |
| Non-Bracing Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 12 | 8.1 units on a scale | Standard Deviation 11.5 |
| Non-Bracing Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) | Change at month 24 | 4.6 units on a scale | Standard Deviation 10.3 |
Comparison: Difference between baseline and month 6.p-value: 0.162Regression, Linear
Comparison: Difference between baseline and month 12.p-value: 0.094Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.043Regression, Linear
Secondary
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Change From Baseline in Cartilage Thickness (Radiographic Outcome) | Change at month 12 | 0.3 mm | Standard Deviation 0.3 |
| Unloader Bracing | Change From Baseline in Cartilage Thickness (Radiographic Outcome) | Change at month 24 | 0.3 mm | Standard Deviation 0.3 |
| Non-Bracing Arm | Change From Baseline in Cartilage Thickness (Radiographic Outcome) | Change at month 12 | -0.2 mm | Standard Deviation 0.4 |
| Non-Bracing Arm | Change From Baseline in Cartilage Thickness (Radiographic Outcome) | Change at month 24 | 0.1 mm | Standard Deviation 0.2 |
Comparison: Difference between baseline and month 12.p-value: 0.02Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.091Regression, Linear
Secondary
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Change From Baseline in Cartilage Volume (Radiographic Outcome) | Change at month 12 | 31.4 mm^3 | Standard Deviation 31.8 |
| Unloader Bracing | Change From Baseline in Cartilage Volume (Radiographic Outcome) | Change at month 24 | 49.2 mm^3 | Standard Deviation 35.8 |
| Non-Bracing Arm | Change From Baseline in Cartilage Volume (Radiographic Outcome) | Change at month 12 | -2.1 mm^3 | Standard Deviation 37.5 |
| Non-Bracing Arm | Change From Baseline in Cartilage Volume (Radiographic Outcome) | Change at month 24 | 17.8 mm^3 | Standard Deviation 52.3 |
Comparison: Difference between baseline and month 12.p-value: 0.064Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.276Regression, Linear
Secondary
Change From Baseline in Lysholm Score (Clinical Outcome)
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.
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 6 | 14.3 units on a scale | Standard Deviation 16.2 |
| Unloader Bracing | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 12 | 25.7 units on a scale | Standard Deviation 33.9 |
| Unloader Bracing | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 24 | 20.3 units on a scale | Standard Deviation 20.5 |
| Non-Bracing Arm | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 6 | 11.1 units on a scale | Standard Deviation 23.1 |
| Non-Bracing Arm | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 12 | 20.3 units on a scale | Standard Deviation 21.7 |
| Non-Bracing Arm | Change From Baseline in Lysholm Score (Clinical Outcome) | Change at month 24 | 18.8 units on a scale | Standard Deviation 17.1 |
Comparison: Difference between baseline and month 6.p-value: 0.733Regression, Linear
Comparison: Difference between baseline and month 12.p-value: 0.666Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.854Regression, Linear
Secondary
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
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.
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | 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 |
| Unloader Bracing | 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 |
| Unloader Bracing | 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 |
| Non-Bracing Arm | Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | Change at month 6 | 2.9 units on a scale | Standard Deviation 5.5 |
| Non-Bracing Arm | Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | Change at month 12 | 2.3 units on a scale | Standard Deviation 3 |
| Non-Bracing Arm | Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) | Change at month 24 | 2.1 units on a scale | Standard Deviation 6.8 |
Comparison: Difference between baseline and month 6.p-value: 0.729Regression, Linear
Comparison: Difference between baseline and month 12.p-value: 0.958Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.634Regression, Linear
Secondary
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | Change at month 12 | -24.5 millisecond (ms) | Standard Deviation 25.3 |
| Unloader Bracing | Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | Change at month 24 | -25.1 millisecond (ms) | Standard Deviation 25.1 |
| Non-Bracing Arm | Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | Change at month 12 | -36.2 millisecond (ms) | Standard Deviation 73.8 |
| Non-Bracing Arm | Change From Baseline in T2 Relaxation Time (Radiographic Outcome) | Change at month 24 | -17.6 millisecond (ms) | Standard Deviation 5.6 |
Comparison: Difference between baseline and month 12.p-value: 0.774Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.414Regression, Linear
Secondary
Change From Baseline in Tegner Score (Clinical Outcome)
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.
Time frame: 2 years
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unloader Bracing | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 6 | 1.7 units on a scale | Standard Deviation 1.2 |
| Unloader Bracing | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 12 | 2.7 units on a scale | Standard Deviation 1.1 |
| Unloader Bracing | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 24 | 2.3 units on a scale | Standard Deviation 1.9 |
| Non-Bracing Arm | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 24 | 1.4 units on a scale | Standard Deviation 1.2 |
| Non-Bracing Arm | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 6 | 0.9 units on a scale | Standard Deviation 2.6 |
| Non-Bracing Arm | Change From Baseline in Tegner Score (Clinical Outcome) | Change at month 12 | 1.9 units on a scale | Standard Deviation 2.2 |
Comparison: Difference between baseline and month 6.p-value: 0.387Regression, Linear
Comparison: Difference between baseline and month 12.p-value: 0.34Regression, Linear
Comparison: Difference between baseline and month 24.p-value: 0.179Regression, Linear