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Active, Not Recruiting

NCT Number: NCT07255547

PRP vs AD-SVF in Addition to Marrow Stimulation for Knee Chondral Lesion

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Chondral Lesion Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Salvatore Hospital

L’Aquila, Abruzzo, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • knee pain and functional limitation for at least three months, monocompartmental chondral lesion < 2 cm2, age over 18, and BMI between 18.5 and 30

Exclusion criteria

  • previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit > 20° or extension deficit >15°, genu valgum or genu varum > 20°, patients with Hb values < 11 g/dL or platelet < 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.

Treatment and study plan

Bone Marrow Stimulation

Procedure

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.

Other names: knee arthroscopy, Steadman microfracture

stromal vascular fraction (SVF)

Combination Product

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.

Other names: PRP injection

PRP injection

Drug

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.

Primary outcomes

  1. Change from baseline in knee clinical function questionnaire (KOOS)

    Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.

    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.

Secondary outcomes

  1. Knee pain assessment

    Time frame: From preoperatively (baseline) until the end of the study, up to 60 months.

    Pain intensity was measured using the Visual Analogue Scale (VAS).

  2. Adverse events after the procedure

    Time frame: Until the end of the study, up to 60 months.

    Adverse events such as knee swelling and pain with longer recovery time

  3. Other Patient-Reported Outcome Measures

    Time frame: From preoperatively (baseline) to the end of the study, up to 60 months.

    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.

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Aquila

Other

Collaborators

  • Arthrex GmbH

Registry information

Official study title

Arthrosocpic Treatment of Knee Chondral Lesions: Clinical, MRI and Histologic Comparison Between the Use of PRP vs ADSCs in Addition to Marrow Stimulation Techniques

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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