RecruitingNot ApplicableNCT07473947

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

Enrollment

80 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fracture fixation operation for people with ankle fractures, elbow fractures, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFracture 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

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NCT07473947


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