Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus

Peking University

Status

Enrolling

Conditions

Platelet Rich Plasma

Microfractures

Osteochondral Lesion of Talus

Treatments

Procedure: Arthroscopic microfracture with intraoperative local PRP gel injection

Procedure: Isolated microfracture

Study type

Interventional

Funder types

Other

Identifiers

NCT06358807

M2023438

Details and patient eligibility

About

The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:

Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.

Participants will:

Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
Take MRI preoperatively and 6, 12 and 24 months after surgery

Enrollment

70 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
Conservative treatment of at least 3 months fails to relieve symptoms;
Willingness to voluntarily participate in the trial and to sign informed consent.

Exclusion criteria

Varus or valgus deformity of the ankle of more than 5 degrees;
Grade III injury of the lateral collateral ligament of ankle;
Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
Joint fibrosis, stiffness, and significantly restricted range of motion;
Evidence of moderate to severe knee osteoarthritis on plain radiographs;
Failure to complete the rehabilitation protocol as required;
Patient medically not fit for surgery, radiographs or MRI;
For women, pregnant, planning to be pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Microfracture with PRP

Experimental group

Description:

Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local injection: PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope.

Treatment:

Procedure: Arthroscopic microfracture with intraoperative local PRP gel injection

Isolated microfracture

Active Comparator group

Description:

Treatment:

Procedure: Isolated microfracture