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

Not Applicable

Recruiting

• Conditions: Osteochondral Lesion of Talus; Microfractures; Platelet Rich Plasma
• Interventions: Procedure: Arthroscopic microfracture with intraoperative local PRP gel injection; Procedure: Isolated microfracture

• Registration Number: NCT06358807
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-01-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfracture with PRP	Arthroscopic microfracture with intraoperative local PRP gel injection	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.
Isolated microfracture	Isolated microfracture	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.

Primary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society Score (AOFAS)	Pre-surgery and 3, 6, 12 and 24 months after surgery	The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	Final follow-up (24 months after surgery)	Patient satisfaction will be graded as 0-10 and collected 24 months after surgery.
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)	Twelve and 24 months after surgery	MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.
Return-to-Sport Rate	Final follow-up (24 months after surgery)	The rate and time point of participants returning to sports will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.
Foot and Ankle Outcome Score (FAOS)	Pre-surgery and 3, 6, 12 and 24 months after surgery	The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Ankle Activity Score (AAS)	Pre-surgery and 3, 6, 12 and 24 months after surgery	The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Visual Analogue Scale (VAS)	Pre-surgery and 3, 6, 12 and 24 months after surgery	The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Complications	Final follow-up (24 months after surgery)	Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China