NCT07112885

Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis

Completed NA Results posted Last updated 22 September 2025

What this trial tests

NA trial testing Arthroscopic Microfracture Combined with Autologous SVF Injection in Knee Osteoarthritis (Knee OA) in 50 participants. Completed in 3 May 2025.

Timeline

2 February 2023

Primary endpoint
7 April 2025

3 May 2025

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	2 February 2023
Primary completion	7 April 2025
Estimated completion	3 May 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Arthroscopic Microfracture Combined with Autologous SVF Injection
• Arthroscopic Debridement Followed by Autologous SVF Injection

Conditions studied

• Knee Osteoarthritis (Knee OA) — all drugs for Knee Osteoarthritis (Knee OA) →

Sponsor

Istanbul University

Who can join

Adults 49 to 71, any sex, with Knee Osteoarthritis (Knee OA). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Primary · Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

The WOMAC index (range: 0-96) is a validated questionnaire evaluating pain, stiffness, and physical function in osteoarthritis patients. Higher scores indicate worse symptoms. This outcome measures change in WOMAC score following SVF therapy with or without microfracture.

Outcomes at 3 Months

Group	Value	95% CI
Microfracture Plus SVF Group	49.52	± 7.58
SVF Only Group	50.60	± 8.64

Outcomes at 6 Months

Group	Value	95% CI
Microfracture Plus SVF Group	34.16	± 16.32
SVF Only Group	49.96	± 7.87

Outcomes at 12 Months

Group	Value	95% CI
Microfracture Plus SVF Group	33.88	± 5.98
SVF Only Group	47.16	± 7.02

Outcomes at 24 Months

Group	Value	95% CI
Microfracture Plus SVF Group	33.48	± 6.40
SVF Only Group	47.08	± 7.68

Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score) Primary · Baseline and 12,24 months after the intervention

The WORMS cartilage subscore (range: 0-84) is a semiquantitative MRI-based system assessing the morphology and integrity of articular cartilage in the knee joint. Higher scores indicate more severe cartilage damage. This outcome specifically evaluates radiological changes in cartilage structure after SVF therapy with or without microfracture.

Outcomes at 12 Months

Group	Value	95% CI
Microfracture Plus SVF Group	41.28	± 2.48
SVF Only Group	68.76	± 2.80

Outcomes at 24 Months

Group	Value	95% CI
Microfracture Plus SVF Group	40.64	± 2.72
SVF Only Group	66.80	± 6.25

Change in Lysholm Knee Score Secondary · Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

The Lysholm Knee Score (range: 0-100) is a validated tool assessing knee function, including pain, instability, and swelling. Higher scores indicate better knee function.

Outcomes at 3 Months

Group	Value	95% CI
Microfracture Plus SVF Group	46.80	± 4.76
SVF Only Group	47.6	± 5.02

Outcomes at 6 Months

Group	Value	95% CI
Microfracture Plus SVF Group	47.40	± 5.02
SVF Only Group	46.40	± 4.68

Outcomes at 12 Months

Group	Value	95% CI
Microfracture Plus SVF Group	82.20	± 5.02
SVF Only Group	82.20	± 5.02

Outcomes at 24 Months

Group	Value	95% CI
Microfracture Plus SVF Group	82.00	± 4.08
SVF Only Group	82.40	± 5.61

Change in VAS (Visual Analog Scale) for Pain Secondary · Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

The VAS for pain (range: 0-10) is a subjective scale assessing pain intensity, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

Outcomes at 3 Months

Group	Value	95% CI
Microfracture Plus SVF Group	5.60	± 1.04
SVF Only Group	6.28	± 1.06

Outcomes at 6 Months

Group	Value	95% CI
Microfracture Plus SVF Group	5.96	± 1.17
SVF Only Group	6.16	± 1.07

Outcomes at 12 Months

Group	Value	95% CI
Microfracture Plus SVF Group	2.76	± 0.78
SVF Only Group	5.76	± 1.13

Outcomes at 24 Months

Group	Value	95% CI
Microfracture Plus SVF Group	2.76	± 0.66
SVF Only Group	5.40	± 0.91

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.