Clinical trial NCT02016300: Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
Official title: Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Loss
Microfracture
Keywords: cartilage
microfracture
knee
bracing
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
timeFrame: 2 years
Secondary outcomes:
measure: Change From Baseline in Tegner Score (Clinical Outcome)
timeFrame: 2 years
measure: Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
timeFrame: 2 years
measure: Change From Baseline in Lysholm Score (Clinical Outcome)
timeFrame: 2 years
measure: Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
timeFrame: 2 years
measure: Change From Baseline in Cartilage Volume (Radiographic Outcome)
timeFrame: 2 years
measure: Change From Baseline in Cartilage Thickness (Radiographic Outcome)
timeFrame: 2 years
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Jason Dragoo, MD
role: PRINCIPAL_INVESTIGATOR
References: