Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)
Primary Purpose
Cartilage Loss, Microfracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unloader Bracing
Non-Bracing
Sponsored by
About this trial
This is an interventional treatment trial for Cartilage Loss focused on measuring cartilage, microfracture, knee, bracing
Eligibility Criteria
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
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Unloader Bracing
Non-Bracing Arm
Arm Description
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
This group will be randomly selected and assigned to wear no brace post-operatively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02016300
Brief Title
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
Acronym
Mfxbracing
Official Title
Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Loss, Microfracture
Keywords
cartilage, microfracture, knee, bracing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unloader Bracing
Arm Type
Experimental
Arm Description
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
Arm Title
Non-Bracing Arm
Arm Type
Active Comparator
Arm Description
This group will be randomly selected and assigned to wear no brace post-operatively.
Intervention Type
Device
Intervention Name(s)
Unloader Bracing
Other Intervention Name(s)
Ossur Unloader Brace
Intervention Description
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Intervention Type
Device
Intervention Name(s)
Non-Bracing
Intervention Description
Microfracture performed with no post-operative unloader bracing
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Tegner Score (Clinical Outcome)
Description
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
Title
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Description
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
Title
Change From Baseline in Lysholm Score (Clinical Outcome)
Description
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
Title
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Description
T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
Time Frame
2 years
Title
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Time Frame
2 years
Title
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Dragoo, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
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