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
Inion Oy
80 participants
May 29, 2026
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
Inclusion Criteria1
- \. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability < 18 years 3. Suitable and in need for an operation indicated for subject device 4. Ability to give adequate input for the PROM questionnaires 5. Willingness and ability to comply with rehabilitation instructions. 6. Availability for follow-up visits.
Exclusion Criteria7
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)
- Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
- Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- Patients with known allergy to the implant constituents or its degradation products.
- Spinal and craniomaxillofacial indications.
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
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Interventions
Fracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07473947