Overview

This trial is active, not recruiting.

Conditions cartilage loss, microfracture
Treatments unloader bracing, non-bracing
Sponsor Stanford University
Start date January 2013
End date January 2017
Trial size 20 participants
Trial identifier NCT02016300, oss-mfx-2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
unloader bracing Ossur Unloader Brace
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
(Active Comparator)
This group will be randomly selected and assigned to wear no brace post-operatively.
non-bracing
Microfracture performed with no post-operative unloader bracing

Primary Outcomes

Measure
Clinical Outcome, Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 2 years

Secondary Outcomes

Measure
Radiographic Outcome, Quantitative T1 Rho Analyisis on MRI
time frame: 2 years
Clinical Outcome, Tegner score
time frame: 2 years
Clinical Outcome, VR-12 score
time frame: 2 years
Clinical Outcome, Lysholm Score
time frame: 2 years
Clinical Outcome, Visual Analogue Scale (VAS)
time frame: 2 years
Radiographic Outcome, MRI with Quantitative T2 Mapping
time frame: 2 years

Eligibility Criteria

Male or female participants from 15 years up to 40 years old.

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

Additional Information

Official title Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
Principal investigator Jason Dragoo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Stanford University.