Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06358807

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

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

70

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding a local injection of platelet rich plasma (PRP) gel to arthroscopic microfracture surgery improves treatment for osteochondral lesions of the talus (OLT), a condition causing chronic ankle pain. This randomized, double-blind trial compares combined PRP gel injection with isolated microfracture surgery. The study aims to see if the combined approach enhances ankle function based on the American Orthopedic Foot and Ankle Society (AOFAS) Score and improves cartilage healing as seen on MRI scans. Participants receive either isolated arthroscopic microfracture surgery or the same surgery combined with PRP gel injection prepared from the participant's own blood. During surgery, damaged cartilage and bone are cleaned, and microfracture channels are created in the lesion. For the experimental group, PRP gel is made by processing the participant's blood and injected directly into the injured area under arthroscopic guidance. The study includes follow-ups at 3, 6, 12, and 24 months to assess outcomes. Throughout the trial, participants undergo clinical assessments of ankle function using various scales including AOFAS, Foot and Ankle Outcome Score, and Visual Analogue Scale at multiple time points before and after surgery. MRI scans are performed preoperatively and at 6, 12, and 24 months post-surgery to monitor cartilage repair. Researchers also track patient satisfaction, return-to-sport rates, and any complications up to 24 months. The total participation lasts about two years with regular clinical and imaging evaluations.

CONDITIONS

Brief 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
  • Failed to relieve symptoms after at least 3 months of conservative treatment
  • Willingness to participate voluntarily and sign informed consent
Not Eligible

You will not qualify if you...

  • Varus or valgus deformity of the ankle 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 restricted range of motion
  • Moderate to severe knee osteoarthritis shown on plain radiographs
  • Failure to complete the required rehabilitation protocol
  • Medically unfit for surgery or imaging procedures
  • Women who are pregnant, planning to become pregnant, or breastfeeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo arthroscopic microfracture surgery, with or without local injection of platelet rich plasma gel, to treat osteochondral lesions of the talus.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 24 months after surgery

Participants are monitored and assessed for recovery and treatment efficacy after surgery.

Visits at 3, 6, 12, and 24 months after surgery (in-person)

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

F

Fengyi Hu, MD

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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