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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Microfracture performed with no post-operative unloader bracing
Stanford University Medical Center
Redwood City, California, United States
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
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
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
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
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
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Time frame: 2 years
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Time frame: 2 years
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