Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06358807

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

Led by Peking University Third Hospital · Updated on 2024-05-20

70

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic ankle pain diagnosed as osteochondral lesion of the talus
  • Lesion size less than or equal to 1.5 cm2 or diameter less than or equal to 1.5 cm
  • Symptoms not relieved after at least 3 months of conservative treatment
  • Willingness to participate voluntarily and sign informed consent
Not Eligible

You will not qualify if you...

  • Ankle varus or valgus deformity greater than 5 degrees
  • Grade III injury of the lateral collateral ligament of the ankle
  • Chronic synovitis such as rheumatoid arthritis or pigmented villous nodular synovitis
  • Joint fibrosis, stiffness, or significantly limited range of motion
  • Moderate to severe knee osteoarthritis seen on X-rays
  • Failure to complete required rehabilitation protocol
  • Medically unfit for surgery, radiographs, or MRI
  • Women who are pregnant, planning pregnancy, or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

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Research Team

Q

Qinwei Guo, MD

CONTACT

F

Fengyi Hu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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