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

NCT07112885 | Completed Results

• 1 other identifier: IU-ORT-MYY-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis (Knee OA)

Keywords

microfracture; Stromal Vascular Fraction; Cartilage Repair; WOMAC; WORMS; Regenerative Medicine

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

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

  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.

  Baseline and 12,24 months after the intervention

Secondary Outcomes (2)

• Change in Lysholm Knee Score

  Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

• Change in VAS (Visual Analog Scale) for Pain

  Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention

Study Arms (2)

Microfracture Plus SVF Group

EXPERIMENTAL

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

Procedure: Arthroscopic Microfracture Combined with Autologous SVF Injection

SVF Only Group

EXPERIMENTAL

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

Procedure: Arthroscopic Debridement Followed by Autologous SVF Injection

Interventions

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

Microfracture Plus SVF Group

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.

SVF Only Group

Eligibility Criteria

• Age: 49 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Medicine

Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (2)

• Nguyen PD, Tran TD, Nguyen HT, Vu HT, Le PT, Phan NL, Vu NB, Phan NK, Van Pham P. Comparative Clinical Observation of Arthroscopic Microfracture in the Presence and Absence of a Stromal Vascular Fraction Injection for Osteoarthritis. Stem Cells Transl Med. 2017 Jan;6(1):187-195. doi: 10.5966/sctm.2016-0023. Epub 2016 Aug 29.

  PMID: 28170179 RESULT

• Bisicchia S, Bernardi G, Pagnotta SM, Tudisco C. Micro-fragmented stromal-vascular fraction plus microfractures provides better clinical results than microfractures alone in symptomatic focal chondral lesions of the knee. Knee Surg Sports Traumatol Arthrosc. 2020 Jun;28(6):1876-1884. doi: 10.1007/s00167-019-05621-0. Epub 2019 Jul 11.

  PMID: 31297576 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Fractures, Stress

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone; Wounds and Injuries

Limitations and Caveats

The study is limited by its 24-month follow-up, without long-term data. Cartilage quality was assessed indirectly with WORMS scores, and variability in SVF composition across patients may have influenced outcomes.

Results Point of Contact

• Title: Mehmet Yağız Yenigün, MD (Principal Investigator)
• Organization: Istanbul University, Department of Orthopedics and Traumatology

mehmet.yenigun@istanbul.edu.tr

+905544383142

Study Officials

• Yağız M Yenigün

  Istanbul University Faculty of Medicine, Topkapi, Turgut Ozal Millet Street, 34093 Fatih/Istanbul

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to their treatment allocation throughout the study. Although the operating surgeons were aware of the intervention due to the nature of the surgical procedures, outcome assessment was conducted by an independent radiologist who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: Two-group parallel design: Group A received arthroscopic microfracture combined with stromal vascular fraction injection, while Group B received stromal vascular fraction injection alone.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: February 2, 2023
• Primary Completion: April 7, 2025
• Study Completion: May 3, 2025
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)