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

Università degli Studi dell'Aquila

Status and phase: Active, not recruiting; Phase 4

Conditions: Knee Chondral Lesion

Treatments: Drug: PRP injection; Combination Product: stromal vascular fraction (SVF); Procedure: Bone Marrow Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07255547

23/2019

EMEA-18060 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

PRP

Active Comparator group

Description:

In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.

Treatment:

Procedure: Bone Marrow Stimulation

Drug: PRP injection

PRP + AD-SVF

Experimental group

Description:

In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.

Treatment:

Procedure: Bone Marrow Stimulation

Combination Product: stromal vascular fraction (SVF)