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.
None
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.)
Single group
Fracture fixation operation
DeviceFracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use
Bone healing (ossification) of the fracture line(s)
X-ray evaluation of bone healing (ossification) of the fracture line(s)
Occurrence of device-related adverse events
Assessment of occurrence of adverse events (AE), that are or might be related to the study device such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption
Occurrence of revision surgeries
Assessment of occurrence of revision surgeries related to study device
Subjective functionality of the operated limb (Visual Analogue Scale, VAS)
Evaluation of subjective pain of the operated area during follow-up. 10-cm (100-mm) horizontal line used to measure pain intensity, ranging from "no pain" (0) to "worst imaginable pain" (100 mm)
Subjective functionality of the operated area (Lower Extremity Functional Scale, LEFS/Upper Extremity Functional Index, UEFI)
Evaluation of subjective functionality of the operated area follow-up. UEFI: The scores given to the 20 questions are added to give a highest possible score of 80. The lowest possible score is 0. A lower score indicates that the person is reporting increased difficulty with the activities as a result of their upper limb condition. LEFS: Contains 20 questions about a person's ability to perform everyday tasks. The maximum score is 80. The lower the score the greater the disability.
