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

Istanbul University

Status: Completed

Conditions: Knee Osteoarthritis (Knee OA)

Treatments: Procedure: Arthroscopic Microfracture Combined with Autologous SVF Injection; Procedure: Arthroscopic Debridement Followed by Autologous SVF Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07112885

IU-ORT-MYY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 49 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Microfracture Plus SVF Group

Experimental group

Description:

Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.

Treatment:

Procedure: Arthroscopic Microfracture Combined with Autologous SVF Injection

SVF Only Group

Experimental group

Description:

Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.

Treatment:

Procedure: Arthroscopic Debridement Followed by Autologous SVF Injection