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

Stanford University

Status: Completed

Conditions: Cartilage Loss; Microfracture

Treatments: Device: Non-Bracing; Device: Unloader Bracing

Study type: Interventional

Funder types: Other

Identifiers

NCT02016300

oss-mfx-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Unloader Bracing

Experimental group

Description:

This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.

Treatment:

Device: Unloader Bracing

Non-Bracing Arm

Active Comparator group

Description:

This group will be randomly selected and assigned to wear no brace post-operatively.

Treatment:

Device: Non-Bracing