Bioabsorbable headless screws for ankle, knee, and elbow fractures in kids and teens

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 is a post-market clinical follow-up to monitor safety and performance of the bioabsorbable Inion CompressOn headless screws used for fracture fixation in the ankle, knee, and elbow of pediatric and adolescent patients. It aims to enroll 80 participants at a single center, Turku University Hospital in Finland, and follow each patient for four years. The study focuses on bone healing/ossification at operated sites and on adverse events or revision surgeries related to the device. The screw material degrades over up to four years, and the data collection supports CE certification as part of post-market surveillance. The design is a single-group, non-comparative approach without a control arm.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability \< 18 years 3. Suitable and in need for an operation indicated for subject device 4. Ability to give adequate input for the PROM questionnaires 5. Willingness and ability 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 or upper 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. Patients with known allergy to the implant constituents or its degradation products.
6. Spinal and craniomaxillofacial indications.
7. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation

Where it's running

• Turku University Hospital/Lighthouse hospital
  Turku, Finland Recruiting

Study contacts

• Principal investigator: Olli Pajulo, MD — Turku University Hospital
• Study coordinator: Marika Manni, MD
• Email: marika.manni@inion.com
• Phone: +358503669994

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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.