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

NCT07255547 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-01

No results posted yet for this study

Summary

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.

Conditions

  • Knee Chondral Lesion

Interventions

PROCEDURE

Bone Marrow Stimulation

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.

COMBINATION_PRODUCT

stromal vascular fraction (SVF)

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.

DRUG

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.

Sponsors & Collaborators

  • Arthrex GmbH

    collaborator INDUSTRY

  • Università degli Studi dell'Aquila

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255547 on ClinicalTrials.gov