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RECRUITING
NCT05555459
NA

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

Sponsor: Inion Oy

View on ClinicalTrials.gov

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.

Official title: The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2023-03-07

Completion Date

2032-04-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

PROCEDURE

Operation

Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s

Locations (1)

Tampere University Hospital

Tampere, Finland