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Search / Trial NCT06358807

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

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Apr 7, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Osteochondral Lesion Of Talus Microfractures Platelet Rich Plasma Arthroscopic Techniques Clinical Efficacy

ClinConnect Summary

This clinical trial is studying a treatment for a condition called osteochondral lesion of the talus, which is a type of injury to the cartilage in the ankle. The researchers want to find out if combining a procedure called arthroscopic microfracture—where small holes are made in the bone to help it heal—with an injection of platelet-rich plasma (PRP) gel can improve ankle function better than just the microfracture alone. They will look at how well patients recover over time, using specific scoring systems and MRI scans to check the healing of the cartilage.

To participate in this trial, individuals should be between 18 and 75 years old and have chronic ankle pain due to an osteochondral lesion that hasn’t improved after at least three months of other treatments. Participants will either receive just the microfracture treatment or the microfracture with the PRP gel injection. They will have follow-up appointments at 3, 6, 12, and 24 months after surgery to assess their ankle function and take imaging tests to monitor healing. It’s important to note that certain conditions, like severe ankle deformities or other joint diseases, may exclude someone from participating.

Gender

ALL

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.

About Peking University Third Hospital

Peking University Third Hospital is a leading medical institution in China, renowned for its commitment to advanced healthcare, innovative research, and comprehensive clinical services. As a prominent sponsor of clinical trials, the hospital emphasizes the integration of cutting-edge scientific research with patient-centered care to enhance therapeutic outcomes. With a multidisciplinary approach, the institution fosters collaboration among top-tier medical professionals and researchers, striving to contribute to the global medical community through rigorous clinical studies that address pressing health challenges. Its dedication to ethical standards and regulatory compliance ensures the safety and efficacy of new treatments, ultimately aiming to improve patient care and outcomes on both a national and international scale.

Locations

Beijing, Beijing, China

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Qinwei Guo, MD

Principal Investigator

Department of Sports Medicine, Peking University Third Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported