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Recruiting NCT06358807

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

No phase Interventional Osteochondral Lesion of Talus Microfractures Platelet Rich Plasma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arthroscopic microfracture with intraoperative local PRP gel injection, Isolated microfracture.
Who it may be relevant to
Registry conditions: Osteochondral Lesion of Talus, Microfractures, Platelet Rich Plasma. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • 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
  • Procedure 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

  • American Orthopedic Foot and Ankle Society Score (AOFAS) [Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery]
Secondary outcome measures (7)
  • Foot and Ankle Outcome Score (FAOS) [Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery]
  • Ankle Activity Score (AAS) [Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery]
  • Visual Analogue Scale (VAS) [Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery]
  • Patient Satisfaction [Time frame: Final follow-up (24 months after surgery)]
  • Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) [Time frame: Twelve and 24 months after surgery]
  • Return-to-Sport Rate [Time frame: Final follow-up (24 months after surgery)]
  • Complications [Time frame: Final follow-up (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT06358807 · M2023438

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗