NCT07112885

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

Effect of Arthroscopic Microfracture Combined With Stromal Vascular Fraction Therapy on Clinical and Radiological Outcomes in Gonarthrosis: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 49 Years – 71 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This single-center, prospective, randomized controlled clinical study was conducted to compare the efficacy of stromal vascular fraction (SVF) therapy alone versus SVF therapy combined with arthroscopic microfracture in patients diagnosed with knee osteoarthritis (gonarthrosis). A total of 50 patients with symptomatic medial compartment osteoarthritis, classified as Kellgren-Lawrence grade II-III, were enrolled and randomized into two groups: Group A (n=25): Participants initially underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) Group B (n=25): Participants underwent arthroscopic debridement, after which intra-articular injection of autologous stromal vascular fraction (SVF) was administered. Microfracture was not performed in this group. SVF was isolated from autologous lipoaspirate obtained via mini-liposuction and processed intraoperatively using a closed system. Arthroscopic microfracture was performed with standard technique, targeting cartilage defects in the medial and lateral femoral condyle. Clinical evaluations were performed preoperatively and at 3, 6, 12, and 24 months post-intervention using: Visual Analog Scale (VAS) for pain Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Lysholm Knee Scoring Scale Radiological outcomes were assessed using 3.0 Tesla MRI and scored with the Whole-Organ Magnetic Resonance Imaging Score (WORMS), focusing on cartilage integrity in predefined regions. The primary endpoint was the improvement in WOMAC score.Cartilage morphology based on WORMS at 12 and 24 months. Secondary endpoints included changes in Lysholm and VAS scores. Inter-group comparisons were analyzed using appropriate statistical methods with a significance threshold of p \< 0.05. The study aims to explore whether the addition of microfracture to SVF therapy yields superior clinical and structural benefits, potentially guiding future treatment protocols for early to moderate knee osteoarthritis.

Conditions

• Knee Osteoarthritis (Knee OA)

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic Microfracture Combined with Autologous SVF Injection	This procedure involved arthroscopic debridement and microfracture of the knee joint. After microfracture, autologous SVF, isolated from adipose tissue through mechanical digestion and centrifugation, was administered intra-articularly under sterile conditions
PROCEDURE	Arthroscopic Debridement Followed by Autologous SVF Injection	This procedure included only arthroscopic debridement of the knee joint. After debridement, autologous SVF, isolated in the same manner from adipose tissue, was injected into the joint space intra-articularly without microfracture.

Timeline

• Start date: 2023-02-02
• Primary completion: 2025-04-07
• Completion: 2025-05-03
• First posted: 2025-08-08
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: Turkey (Türkiye)