Knee Osteoarthritis (Knee OA)NCT07112885
Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis
A study testing Arthroscopic Microfracture Combined with Autologous SVF Injection and Arthroscopic Debridement Followed by Autologous SVF Injection in people with Knee Osteoarthritis (Knee OA), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 71 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Arthroscopic Microfracture Combined with Autologous SVF Injection and Arthroscopic Debridement Followed by Autologous SVF Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2023to 3 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Medicine
Istanbul, 34320
About this study
Official title: Effect of Arthroscopic Microfracture Combined With Stromal Vascular Fraction Therapy on Clinical and Radiological Outcomes in Gonarthrosis: A Prospective Randomized Controlled Trial
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.
Read the 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)
- Being tested
- Arthroscopic Microfracture Combined with Autologous SVF Injection, Arthroscopic Debridement Followed by Autologous SVF Injection
- Keywords
- microfracture, Stromal Vascular Fraction, Cartilage Repair, WOMAC, WORMS, Regenerative Medicine
- Medical subject headings
- Osteoarthritis, Knee, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Microfracture Combined with Autologous SVF InjectionProcedure or surgery
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 InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Arthroscopic Debridement Followed by Autologous SVF Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12,24 months after the intervention
Secondary outcomes (2)
Change in Lysholm Knee Score
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.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
Change in VAS (Visual Analog Scale) for Pain
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.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start2 Feb 2023
- Primary completion7 Apr 2025
- Study completion3 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel design: Group A received arthroscopic microfracture combined with stromal vascular fraction injection, while Group B received stromal vascular fraction injection alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yağız Yenigün, Istanbul University
- Investigators
- Yağız M Yenigün, Principal investigator, Istanbul University Faculty of Medicine, Topkapi, Turgut Ozal Millet Street, 34093 Fatih/Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112885
- Sponsor's protocol ID
- IU-ORT-MYY-01
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28170179Bisicchia 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.
PubMed 31297576
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arthroscopic Microfracture Combined With Stromal Vascular Fraction Therapy on Clinical and Radiological Outcomes in Gonarthrosis: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07112885
- Acronym / sponsor ID
- IU-ORT-MYY-01
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- microfracture, Stromal Vascular Fraction, Cartilage Repair, WOMAC, WORMS, Regenerative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 3 May 2025 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel design: Group A received arthroscopic microfracture combined with stromal vascular fraction injection, while Group B received stromal vascular fraction injection alone.
| Arm | Type | Receives |
|---|---|---|
| Microfracture Plus SVF Group | Experimental | Procedure: Arthroscopic Microfracture Combined with Autologous SVF InjectionParticipants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue. |
| SVF Only Group | Experimental | Procedure: Arthroscopic Debridement Followed by Autologous SVF InjectionParticipants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture. |
Who may qualify
- Ages
- 49 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Microfracture Combined with Autologous SVF InjectionThis 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 | Procedure or surgery | Microfracture Plus SVF Group |
| Arthroscopic Debridement Followed by Autologous SVF InjectionThis 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. | Procedure or surgery | SVF Only Group |
Primary outcome
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.
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.
2 secondary outcomes
Change in Lysholm Knee Score
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
Change in VAS (Visual Analog Scale) for Pain
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28170179Nguyen 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.
- Results publication: PubMed 31297576Bisicchia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yağız M Yenigün principal investigator
Istanbul University Faculty of Medicine, Topkapi, Turgut Ozal Millet Street, 34093 Fatih/Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Microfracture Combined with Autologous SVF Injection and Arthroscopic Debridement Followed by Autologous SVF Injection in people with Knee Osteoarthritis (Knee OA), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07112885, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.