Clinical Trial

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

Recruiting
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Summary
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-09-22; most recent amendment 2026-03-11.
Status change: Not Yet Recruiting → Recruiting 2022-09-30
Trial Details
NCT Number NCT05555459
Lead Sponsor Inion Oy
Conditions Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture, Calcaneus Fracture, Navicular Fracture, Deformity, Foot, Ankle Fractures +11 more
Enrollment 125 participants
Start Date 2023-03-07
Primary Completion 2031-12-31 (estimated)
Study Completion 2032-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-13