N/A
N=24
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
Cartilage Loss · Microfracture
Bottom Line
View on ClinicalTrials.gov: NCT02016300 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) — 12.0; 4.1; 19.1; 8.1 units on a scale — p=0.162
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unloader Bracing (Device); Non-Bracing (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome) |
12.0; 4.1; 19.1; 8.1; 17.8; 4.6 | 0.162 |
| SECONDARY Change From Baseline in Tegner Score (Clinical Outcome) |
1.7; 0.9; 2.7; 1.9; 2.3; 1.4 | 0.387 |
| SECONDARY Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome) |
2.2; 2.9; 2.4; 2.3; 0.8; 2.1 | 0.729 |
| SECONDARY Change From Baseline in Lysholm Score (Clinical Outcome) |
14.3; 11.1; 25.7; 20.3; 20.3; 18.8 | 0.733 |
| SECONDARY Change From Baseline in T2 Relaxation Time (Radiographic Outcome) |
-24.5; -36.2; -25.1; -17.6 | 0.774 |
| SECONDARY Change From Baseline in Cartilage Volume (Radiographic Outcome) |
31.4; -2.1; 49.2; 17.8 | 0.064 |
| SECONDARY Change From Baseline in Cartilage Thickness (Radiographic Outcome) |
0.3; -0.2; 0.3; 0.1 | 0.020 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02016300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.