Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Inv… (NCT05555459) | Clinical Trial Compass
RecruitingNot Applicable
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Finland125 participantsStarted 2023-03-07
Plain-language summary
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult 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 Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Read the patient information bulletin on the study and signed the patient consent form
✓. Adult patient (over 18-year-old)
✓. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
✓. Ability to fill in questionnaires.
✓. Willingness to comply with rehabilitation instructions.
✓. Availability for follow-up visits.
Exclusion criteria
✕. Active infection
✕. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb
✕. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
What they're measuring
1
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines