A Phase 4 interventional study of Bone Marrow Stimulation and stromal vascular fraction (SVF) in Knee Chondral Lesion, sponsored by Università degli Studi dell'Aquila. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Università degli Studi dell'Aquila · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries.
Participants will:
Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP).
Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's enrollment of 80 is above the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →Università degli Studi dell'Aquila is the lead sponsor of 3 studies on the registry; none are open to participants now.
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In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.
Procedure: Bone Marrow Stimulation · Drug: PRP injection
In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.
Procedure: Bone Marrow Stimulation · Combination Product: stromal vascular fraction (SVF)
All patients underwent an arthroscopic procedure (that further confirmed the preoperative diagnosis; i.e. monocompartmental chondral lesion - Outerbridge grade IV) including a concomitant bone marrow stimulation technique (microfracture). According to the technique described by Steadman, the cartilaginous lesion underwent preliminary debridement to remove the damaged cartilage and form a stable edge of healthy tissue and subsequent microfracture with an arthroscopic pick to stimulate the subchondral unit regenerative response.
Also known as: knee arthroscopy, Steadman microfracture
After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.
Also known as: PRP injection
After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections.
Change from baseline in knee clinical function questionnaire (KOOS)
Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved.
Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.
Knee pain assessment
Pain intensity was measured using the Visual Analogue Scale (VAS).
Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.
Adverse events after the procedure
Adverse events such as knee swelling and pain with longer recovery time
Time frame: Until the end of the study, up to 60 months.
Other Patient-Reported Outcome Measures
Overall physical and mental health-related quality of life was assessed with the 12-item Short Form Survey (SF-12). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete.Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Additionally, the IKDC questionnaire was used to measure knee symptoms, functional limitations, and sports activity. An ordinal scoring system is used to assign a score of 0 to responses that signify the lowest level of function or the highest level of symptoms for each item. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a 0-100 scale. Higher scores indicate higher levels of function and lower levels of symptoms.
Time frame: From preoperatively (baseline) to the end of the study, up to 60 months.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — only IPD used in the results publication
Supporting information: Study protocol
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Aquila