New surgical method for treating osteoarthritis in the big toe joint
New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint
Samara State Medical University · NCT05717413
This study tests a new surgery for people with arthritis in their big toe to see if it can improve their movement and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 52 Years to 69 Years |
| Sex | All |
| Sponsor | Samara State Medical University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Samara) |
| Trial ID | NCT05717413 on ClinicalTrials.gov |
What this trial studies
This study focuses on a new surgical approach for patients suffering from osteoarthritis of the first metatarsophalangeal joint, commonly known as Hallux rigidus. It aims to evaluate the effectiveness of metatarsophalangeal joint endoprosthesis as a treatment option. The study will involve patients with varying degrees of arthrosis and will assess the outcomes based on their functional requirements and activity levels. The methodology includes observational assessments of the surgical interventions and their impact on patient mobility and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are working-age individuals with idiopathic, post-traumatic, or degenerative arthrosis of the first metatarsophalangeal joint.
Not a fit: Patients with purulent arthritis, severe osteoporosis, significant bone defects, or chronic vascular diseases with trophic skin changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with severe osteoarthritis of the big toe joint.
How similar studies have performed: Other studies have explored surgical interventions for Hallux rigidus, but this specific approach using endoprosthesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * idiopathic, post-traumatic and degenerative arthrosis of the first metatarsophalangeal joint * working age of patients Exclusion Criteria: * purulent arthritis and osteomyelitis in the forefoot * severe osteoporosis * significant bone defect * trophic skin changes due to chronic vascular diseases
Where this trial is running
Samara
- Clinics of Samara State Medical University — Samara, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: Gennady Kotelnikov, MD
- Email: pavelisaykin@mail.ru
- Phone: 89370781488
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.
Conditions: Osteoarthritis, modeling of critical loads, geometric model of the foot, Endoprosthesis of 1 metatarsophalangeal joint