Status:
UNKNOWN
Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
Lead Sponsor:
National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
Conditions:
Ankle Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle joint cartilage lesions compared to the conventional microfracture method. It involves 40 participants aged 1...
Detailed Description
Introduction: This prospective clinical study aims to investigate the effectiveness of heparin-conjugated gel in treating patients with ankle joint cartilage lesions and to compare its outcomes with ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06028763
Start Date
July 1 2023
End Date
November 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
Astana, Kazakhstan, Z00P5Y5