Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis (NCT07112885) | Clinical Trial Compass
CompletedNot Applicable
Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis
Turkey (Türkiye)50 participantsStarted 2023-02-02
Plain-language 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.
Who can participate
Age range
49 Years – 71 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Timeframe: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
2
Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Timeframe: Baseline and 12,24 months after the intervention