Skip to main content
OpenTrials
Completed

NCT Number: NCT07112885

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Fractures, Bone Fractures, Stress Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

Age range

49 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Medicine

Istanbul, 34320, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Microfracture Combined with Autologous SVF Injection

Procedure

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

Arthroscopic Debridement Followed by Autologous SVF Injection

Procedure

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.

Primary outcomes

  1. Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: 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.

  2. Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)

    Time frame: 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.

Secondary outcomes

  1. Change in Lysholm Knee Score

    Time frame: 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.

  2. Change in VAS (Visual Analog Scale) for Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.