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

NCT06358807 | Recruiting

• 1 other identifier: M2023438
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Osteochondral Lesion of Talus; Microfractures; Platelet Rich Plasma

Keywords

Osteochondral Lesion of Talus; Microfractures; Platelet Rich Plasma; Arthroscopic Techniques; Clinical Efficacy

Outcome Measures

Primary Outcomes (1)

• American Orthopedic Foot and Ankle Society Score (AOFAS)

  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.

  Pre-surgery and 3, 6, 12 and 24 months after surgery

Secondary Outcomes (7)

• Foot and Ankle Outcome Score (FAOS)

  Pre-surgery and 3, 6, 12 and 24 months after surgery

• Ankle Activity Score (AAS)

  Pre-surgery and 3, 6, 12 and 24 months after surgery

• Visual Analogue Scale (VAS)

  Pre-surgery and 3, 6, 12 and 24 months after surgery

• Patient Satisfaction

  Final follow-up (24 months after surgery)

• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)

  Twelve and 24 months after surgery

Study Arms (2)

Microfracture with PRP

EXPERIMENTAL

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.

Procedure: Arthroscopic microfracture with intraoperative local PRP gel injection

Isolated microfracture

ACTIVE COMPARATOR

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.

Procedure: Isolated microfracture

Interventions

Arthroscopic microfracture with intraoperative local PRP gel injection PROCEDURE

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.

Microfracture with PRP

Isolated microfracture PROCEDURE

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.

Isolated microfracture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Qinwei Guo, MD

  Department of Sports Medicine, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinwei Guo, MD

CONTACT

+86 18601129252; guoqinwei@vip.sina.com

Fengyi Hu, MD

CONTACT

+86 13335511505; hfy1322@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2024

Record last verified: 2024-03

Locations

CN (1)