Evaluation of a bioabsorbable screw for foot and ankle surgeries
The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle
This study is testing a new type of screw used in foot and ankle surgeries to see if it helps bones heal safely while breaking down in the body over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inion Oy Industry-sponsored |
| Locations | 1 site (Tampere) |
| Trial ID | NCT05555459 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the Inion CompressOn bioabsorbable headless compression screw in various foot and ankle surgeries, including fractures and osteotomies. It involves 125 adult patients who will undergo surgical procedures requiring bone fixation with these screws. The study will monitor bone healing and any adverse events over a follow-up period of four years at a single center in Tampere University Hospital, Finland. The screws are designed to degrade safely in the body while maintaining strength during the healing process.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who require surgical intervention for specific foot and ankle fractures.
Not a fit: Patients with active infections, severe circulatory disorders, or conditions affecting bone quality may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery times for patients undergoing foot and ankle surgeries.
How similar studies have performed: Other studies have shown promise with bioabsorbable screws in orthopedic applications, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Read the patient information bulletin on the study and signed the patient consent form 2. Adult patient (over 18-year-old) 3. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon 4. Ability to fill in questionnaires. 5. Willingness to comply with rehabilitation instructions. 6. Availability for follow-up visits. Exclusion Criteria: 1. Active infection 2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb 3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder) 4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.) 5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation 6. Patients with significant neuropathy 7. Pregnancy 8. Patients who refuse to participate 9. Lower limb tumor or metastasis 10. Complex Regional Pain Syndrome (CRPS) in operated foot
Where this trial is running
Tampere
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Mäenpää — Tampere University Hospital
- Study coordinator: Marika Manni, MD
- Email: marika.manni@inion.com
- Phone: +358 50 366 9994
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.