N/A
Completed N=50
Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Source: ClinicalTrials.gov NCT07112885 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) — 49.52; 50.60; 34.16; 49.96 Score
Summary
This prospective, randomized controlled clinical trial aims to evaluate the clinical and radiological effects of combining stromal vascular fraction (SVF) therapy with arthroscopic microfracture in patients with knee osteoarthritis. A total of 50 patients with symptomatic gonarthrosis were randomly assigned to either receive arthroscopic debridement and intra-articular SVF injection alone or SVF injection combined with arthroscopic debridement, microfracture. The primary outcome measures include changes in VAS, WOMAC, and Lysholm scores at 3, 6, 12, and 24 months. Radiological assessment was performed using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system. The study hypothesis is that the combination therapy will result in superior clinical and cartilage regeneration outcomes compared to SVF treatment alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) |
49.52; 50.60; 34.16; 49.96; 33.88; 47.16 | — |
| PRIMARY Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score) |
41.28; 68.76; 40.64; 66.80 | — |
| SECONDARY Change in Lysholm Knee Score |
46.80; 47.6; 47.40; 46.40; 82.20; 82.20 | — |
| SECONDARY Change in VAS (Visual Analog Scale) for Pain |
5.60; 6.28; 5.96; 6.16; 2.76; 5.76 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with stage II-III osteoarthritis of the knee
- Patients with a mechanical axis deviation not exceeding 15 mm on the anteroposterior orthoroentgenogram x-ray
Exclusion Criteria
- Patients with deformities on anteroposterior and lateral x-ray examinations
- Patients with a BMI greater than 35 kg/m2
- Patients diagnosed with secondary gonarthrosis (Rheumatoid arthritis, secondary to trauma)
- Patients with a history of intra-articular injections within the last 6 months
- Patients with a history of knee joint surgery
Data sourced from ClinicalTrials.gov (NCT07112885). 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. Informational only — not medical advice.