Clinical trial NCT06358807: Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteochondral Lesion of Talus
Microfractures
Platelet Rich Plasma
Keywords: Osteochondral Lesion of Talus
Microfractures
Platelet Rich Plasma
Arthroscopic Techniques
Clinical Efficacy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society Score (AOFAS)
timeFrame: Pre-surgery and 3, 6, 12 and 24 months after surgery
Secondary outcomes:
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Pre-surgery and 3, 6, 12 and 24 months after surgery
measure: Ankle Activity Score (AAS)
timeFrame: Pre-surgery and 3, 6, 12 and 24 months after surgery
measure: Visual Analogue Scale (VAS)
timeFrame: Pre-surgery and 3, 6, 12 and 24 months after surgery
measure: Patient Satisfaction
timeFrame: Final follow-up (24 months after surgery)
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
timeFrame: Twelve and 24 months after surgery
measure: Return-to-Sport Rate
timeFrame: Final follow-up (24 months after surgery)
measure: Complications
timeFrame: Final follow-up (24 months after surgery)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Department of Sports Medicine, Peking University Third Hospital
name: Qinwei Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: