Safety and Performance Follow-up of Bioabsorbable Headless Inion CompressOn Screws for Fixing Bone Fractures in the Ankle, Knee, and Elbow of Children and Adolescents

What this Trial Is About

This research aims to follow the safety and performance of the bioabsorbable headless Inion CompressOn Screw used to fix fractures in the ankle, knee, and elbow of children and adolescents. The study focuses on monitoring bone healing and the occurrence of any adverse events or revision surgeries related to the device. It is a post-market clinical follow-up study required to confirm the devices performance compared to a similar approved device, conducted at a single center in Finland. Participants receive surgical fracture fixation using the Inion CompressOn Screw, which is made of degradable polymers that retain strength for about 12 weeks and fully absorb within four years. The study includes 80 pediatric and adolescent patients who meet the criteria. Each patient is followed for four years with six key time points screening before surgery, operation day, and four post-operative follow-ups at 4-8 weeks, 3 months, 2 years, and 4 years. The last two follow-ups are specifically for study data collection. During the study, participants will undergo assessments to monitor bone healing and ossification at the fracture site, track any device-related adverse events, and note any revision surgeries needed. Questionnaires will assess the function of the operated limb and area over time. The follow-ups beyond standard care provide detailed performance and safety data over four years, ensuring comprehensive monitoring of outcomes related to the implanted device.

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