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Trial Outcomes & Findings for Comparison of SVF Injection With and Without Microfracture in Moderate Knee Osteoarthritis (NCT NCT07112885)

NCT ID: NCT07112885

Last Updated: 2025-09-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

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

Results posted on

2025-09-22

Participant Flow

Patients with moderate knee osteoarthritis were recruited from Istanbul University orthopedics outpatient clinics between 2022-2025. A total of 50 patients were screened and randomized.All participants met inclusion criteria and provided informed consent.

Seven patients were excluded before assignment due to not meeting eligibility criteria (n=4) or declining participation (n=3).

Participant milestones

Participant milestones
Measure
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.
SVF Only Group
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Microfracture Plus SVF Group
n=25 Participants
Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.
SVF Only Group
n=25 Participants
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
58.8 Years
STANDARD_DEVIATION 5.6 • n=25 Participants
58.6 Years
STANDARD_DEVIATION 5.3 • n=25 Participants
58.7 Years
STANDARD_DEVIATION 5.4 • n=50 Participants
Sex: Female, Male
Female
17 Participants
n=25 Participants
19 Participants
n=25 Participants
36 Participants
n=50 Participants
Sex: Female, Male
Male
8 Participants
n=25 Participants
6 Participants
n=25 Participants
14 Participants
n=50 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Turkey
25 Participants
n=25 Participants
25 Participants
n=25 Participants
50 Participants
n=50 Participants
Baseline WOMAC Score
50.92 Score
STANDARD_DEVIATION 7.49 • n=25 Participants
50.04 Score
STANDARD_DEVIATION 7.38 • n=25 Participants
50.48 Score
STANDARD_DEVIATION 7.37 • n=50 Participants
Baseline Lysholm Score
47.20 Score
STANDARD_DEVIATION 5.02 • n=25 Participants
47.80 Score
STANDARD_DEVIATION 5.02 • n=25 Participants
47.50 Score
STANDARD_DEVIATION 4.97 • n=50 Participants
Baseline VAS (Pain)
6.56 Score
STANDARD_DEVIATION 1.00 • n=25 Participants
6.44 Score
STANDARD_DEVIATION 1.00 • n=25 Participants
6.50 Score
STANDARD_DEVIATION 0.99 • n=50 Participants
Baseline WORMS(Whole-Organ Magnetic Resonance Imaging Score)
68.72 Scores on a scale
STANDARD_DEVIATION 2.48 • n=25 Participants
69.04 Scores on a scale
STANDARD_DEVIATION 2.62 • n=25 Participants
68.88 Scores on a scale
STANDARD_DEVIATION 2.53 • n=50 Participants

PRIMARY outcome

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

Population: All randomized participants (n=50; 25 in the Microfracture plus SVF group and 25 in the SVF only group) completed the 24-month follow-up and were included in the final analysis. Therefore, the analysis population matches the assigned population.

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.

Outcome measures

Outcome measures
Measure
Microfracture Plus SVF Group
n=25 Participants
Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.
SVF Only Group
n=25 Participants
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Outcomes at 3 Months
49.52 Score
Standard Deviation 7.58
50.60 Score
Standard Deviation 8.64
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Outcomes at 6 Months
34.16 Score
Standard Deviation 16.32
49.96 Score
Standard Deviation 7.87
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Outcomes at 12 Months
33.88 Score
Standard Deviation 5.98
47.16 Score
Standard Deviation 7.02
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Outcomes at 24 Months
33.48 Score
Standard Deviation 6.40
47.08 Score
Standard Deviation 7.68

PRIMARY outcome

Timeframe: Baseline and 12,24 months after the intervention

Population: All randomized participants (n=50; 25 in the Microfracture plus SVF group and 25 in the SVF only group) completed the 24-month follow-up and were included in the final analysis. Therefore, the analysis population matches the assigned population.

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.

Outcome measures

Outcome measures
Measure
Microfracture Plus SVF Group
n=25 Participants
Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.
SVF Only Group
n=25 Participants
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Outcomes at 12 Months
41.28 Scores on scale
Standard Deviation 2.48
68.76 Scores on scale
Standard Deviation 2.80
Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Outcomes at 24 Months
40.64 Scores on scale
Standard Deviation 2.72
66.80 Scores on scale
Standard Deviation 6.25

SECONDARY outcome

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

Population: All randomized participants (n=50; 25 in the Microfracture plus SVF group and 25 in the SVF only group) completed the 24-month follow-up and were included in the final analysis. Therefore, the analysis population matches the assigned population.

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.

Outcome measures

Outcome measures
Measure
Microfracture Plus SVF Group
n=25 Participants
Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.
SVF Only Group
n=25 Participants
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Change in Lysholm Knee Score
Outcomes at 3 Months
46.80 Score
Standard Deviation 4.76
47.6 Score
Standard Deviation 5.02
Change in Lysholm Knee Score
Outcomes at 6 Months
47.40 Score
Standard Deviation 5.02
46.40 Score
Standard Deviation 4.68
Change in Lysholm Knee Score
Outcomes at 12 Months
82.20 Score
Standard Deviation 5.02
82.20 Score
Standard Deviation 5.02
Change in Lysholm Knee Score
Outcomes at 24 Months
82.00 Score
Standard Deviation 4.08
82.40 Score
Standard Deviation 5.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Microfracture Plus SVF Group
n=25 Participants
Participants underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF) derived from adipose tissue.
SVF Only Group
n=25 Participants
Participants underwent only arthroscopic debridement. Following this, autologous SVF derived from adipose tissue was injected intra-articularly, without performing microfracture.
Change in VAS (Visual Analog Scale) for Pain
Outcomes at 24 Months
2.76 Score
Standard Deviation 0.66
5.40 Score
Standard Deviation 0.91
Change in VAS (Visual Analog Scale) for Pain
Outcomes at 3 Months
5.60 Score
Standard Deviation 1.04
6.28 Score
Standard Deviation 1.06
Change in VAS (Visual Analog Scale) for Pain
Outcomes at 6 Months
5.96 Score
Standard Deviation 1.17
6.16 Score
Standard Deviation 1.07
Change in VAS (Visual Analog Scale) for Pain
Outcomes at 12 Months
2.76 Score
Standard Deviation 0.78
5.76 Score
Standard Deviation 1.13

Adverse Events

Microfracture Plus SVF Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SVF Only Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehmet Yağız Yenigün, MD (Principal Investigator)

Istanbul University, Department of Orthopedics and Traumatology

Phone: +905544383142

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place