Treatment of ankle cartilage lesions using a new injectable hydrogel
Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel
This study is testing a new injectable gel to see if it can help people with ankle cartilage damage feel better compared to the usual surgery method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov Government |
| Locations | 1 site (Astana) |
| Trial ID | NCT06028763 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a heparin-conjugated gel for treating cartilage lesions in the ankle compared to the conventional microfracture method. It involves 40 participants aged 18 to 65 with localized cartilage defects in the talus bone. Participants will be divided into two groups: one receiving the new hydrogel treatment and the other undergoing standard microfracture surgery. The study aims to assess cartilage repair and patient outcomes over a 12-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with localized cartilage defects in the ankle joint (Outerbridge II-IV).
Not a fit: Patients with advanced osteoarthritis or other significant joint issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective and less invasive option for repairing ankle cartilage lesions.
How similar studies have performed: While the use of biocomposite hydrogels is a novel approach, similar studies have shown promise in cartilage repair, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Astana
- Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov — Astana, Kazakhstan (Recruiting)
Study contacts
- Study coordinator: Dina Saginova, PhD
- Email: sa_dina@mail.ru
- Phone: +77015998758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.