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

NCT ID: NCT07112885

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-05-03

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.

Conditions

Knee Osteoarthritis (Knee OA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microfracture Plus SVF Group

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

Group Type: EXPERIMENTAL

Arthroscopic Microfracture Combined with Autologous SVF Injection

Intervention Type: 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

SVF Only Group

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

Group Type: EXPERIMENTAL

Arthroscopic Debridement Followed by Autologous SVF Injection

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Yağız Yenigün

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yağız M Yenigün

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Istanbul University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 28170179 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31297576 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IU-ORT-MYY-01

Identifier Type: -

Identifier Source: org_study_id