Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel

Launched by NATIONAL SCIENTIFIC CENTER OF TRAUMATOLOGY AND ORTHOPEDICS NAMED AFTER ACADEMICIAN N.D. BATPENOV · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for ankle osteoarthritis, specifically looking at the effectiveness of a special gel made from fat tissue compared to a standard surgery called microfracture. The trial involves 40 participants aged 18 to 65 who have specific types of cartilage damage in their ankle. Participants will be divided into two groups: one will receive the gel treatment, which involves taking a small amount of their fat to create a healing gel, while the other group will undergo the usual microfracture surgery that many doctors currently use.

To be eligible for this trial, participants must have a certain type of cartilage defect in their ankle and agree to take part. However, those with severe or late-stage osteoarthritis, certain infections, or specific health conditions will not be included. Throughout the study, participants will be monitored for a year to see how well each treatment helps with cartilage repair, reduces pain, and improves overall ankle function. This research aims to find better methods for treating cartilage damage and improving patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients with a local defect of articular cartilage of the talus bone (Outerbridge II-IV) of the ankle joint;
• • an area of no more than 3 cm2 for a single defect or 20 cm2 for multiple defects of the cartilaginous tissue of the talus bone of the ankle joint;
• • voluntary consent to participate in the study.
• Exclusion Criteria:
• • age 18\< and \>65
• • progressive osteoarthritis of the ankle joint in the late stages;
• • synovitis of the ankle joint;
• • instability of the ankle joint;
• • BMI\<29.9;
• • presence of non-sanitized foci of chronic infection;
• • severe mental illnesses (schizophrenia, psycho-organic syndrome);
• • hormonal osteopathy;
• • hemiparesis on the side of the proposed operation;
• • neoplasms of other localizations with or without metastases;
• • absence (refusal) of voluntary consent to participate in the study.