Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

Launched by INION OY · Sep 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special type of screw called the Inion CompressOn, which is used in surgeries for various foot and ankle fractures. The goal is to see how well this screw helps bones heal after surgery and to check for any side effects or complications that might occur. The study is taking place at Tampere University Hospital in Finland and will involve 125 adult patients who need surgery on their lower limbs.

To be eligible for the trial, participants must be over 18 years old and need a specific type of surgery that involves using screws to hold bones together in the foot or ankle. They should also be able to complete questionnaires and follow rehabilitation instructions. Patients with certain conditions, such as infections or serious bone issues, won’t be included. If someone joins the study, they can expect to have follow-up visits for up to four years to monitor their recovery and any effects related to the screw. This trial aims to help improve future surgical treatments for foot and ankle injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Read the patient information bulletin on the study and signed the patient consent form
• • 2. Adult patient (over 18-year-old)
• • 3. 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
• • 4. Ability to fill in questionnaires.
• • 5. Willingness to comply with rehabilitation instructions.
• • 6. Availability for follow-up visits.
• Exclusion Criteria:
• • 1. Active infection
• • 2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb
• • 3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
• • 4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
• • 5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
• • 6. Patients with significant neuropathy
• • 7. Pregnancy
• • 8. Patients who refuse to participate
• • 9. Lower limb tumor or metastasis
• • 10. Complex Regional Pain Syndrome (CRPS) in operated foot