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Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Sponsor: Inion Oy
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
Conditions
Interventions
Operation
Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s
Locations (1)
Tampere University Hospital
Tampere, Finland