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

Osteochondral Lesion of Talus Clinical Trial

Official title:

Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358807
• Other study ID #: M2023438
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Peking University Third Hospital
• Contact: Qinwei Guo, MD
• Phone: +86 18601129252
• Email: guoqinwei[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Stress
• Microfractures
• Osteochondral Lesion of Talus
• Platelet Rich Plasma

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Foot and Ankle Outcome Score (FAOS)	The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.	Pre-surgery and 3, 6, 12 and 24 months after surgery
Secondary	Ankle Activity Score (AAS)	The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.	Pre-surgery and 3, 6, 12 and 24 months after surgery
Secondary	Visual Analogue Scale (VAS)	The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.	Pre-surgery and 3, 6, 12 and 24 months after surgery
Secondary	Patient Satisfaction	Patient satisfaction will be graded as 0-10 and collected 24 months after surgery.	Final follow-up (24 months after surgery)
Secondary	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)	MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.	Twelve and 24 months after surgery
Secondary	Return-to-Sport Rate	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.	Final follow-up (24 months after surgery)
Secondary	Complications	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.	Final follow-up (24 months after surgery)