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Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
Sponsor: Inion Oy
Summary
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 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 Lighthouse Hospital at Turku University Hospital (TYKS) in Finland. The main focus of the study in terms of performance is to follow up 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.
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-04
Completion Date
2032-12
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Fracture fixation operation
Fracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use
Locations (1)
Turku University Hospital/Lighthouse hospital
Turku, Finland