Evaluation of a bioabsorbable screw for foot and ankle surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.