Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects

Not Applicable

Completed

• Conditions: Cartilage Loss; Microfracture
• Interventions: Device: Non-Bracing; Device: Unloader Bracing

• Registration Number: NCT02016300
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-05
• Results First Submitted: 2019-05-31
• Results First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Results First Posted: 2019-06-27
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
• age 15-40
• neutral knee alignment

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Exclusion Criteria

• prior cartilage procedures performed in the same knee
• other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Bracing Arm	Non-Bracing	This group will be randomly selected and assigned to wear no brace post-operatively.
Unloader Bracing	Unloader Bracing	This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline in Cartilage Thickness (Radiographic Outcome)	2 years
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 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 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.
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 Cartilage Volume (Radiographic Outcome)	2 years

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Redwood City, California, United States