NCT02016300

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cartilage Loss
• Microfracture

Interventions

Type	Name	Description
DEVICE	Unloader Bracing	The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
DEVICE	Non-Bracing	Microfracture performed with no post-operative unloader bracing

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-12-19
• Last updated: 2019-06-27
• Results posted: 2019-06-27

Locations

1 site across 1 country: United States