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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis (Knee OA)

• Registration Number: NCT07112885
• Lead Sponsor: Istanbul University

Brief 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.

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2025-04-07
• Study Completion: 2025-05-03
• Status Verified: 2025-08
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-02
• Study First Posted: 2025-08-08
• Last Update Submitted: 2025-08-10
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)	Baseline 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.
Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)	Baseline and 24 months after the intervention	The WORMS score (range: 0-332) is a semiquantitative MRI-based system assessing cartilage morphology and joint structure. Higher scores indicate worse structural damage. This outcome evaluates radiological changes after SVF therapy with or without microfracture.

Secondary Outcome Measures

Name	Time	Method
Change in Lysholm Knee Score	Baseline 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.
Change in VAS (Visual Analog Scale) for Pain	Baseline 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.

Trial Locations

Locations (1)

Istanbul University Faculty of Medicine; 🇹🇷 Istanbul, Turkey