RecruitingNot ApplicableNCT05555459

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

The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle

Sponsor

Inion Oy

Enrollment

125 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Medial Malleolus Fracture Lisfranc Injury Lisfranc Fracture Talus Fracture Calcaneus Fracture Navicular Fracture Deformity, Foot Ankle Fractures Foot Fracture Fractures, Bone Fracture of Foot Foot Deformities Foot Injury Feet Deformity Tarsus Metatarsalgia Hallux Rigidus Hallux Valgus Deformity of Toe Deformity of Foot

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of a specialized bone screw called the Inion CompressOn Screw in foot and ankle surgeries. It is a post-market follow-up study to confirm the device continues to perform well in real-world patients. **You may be eligible if:** - You are an adult (over 18 years old) - You need foot or ankle surgery that requires screws to hold bones in place - You are physically able to fill out questionnaires and follow rehabilitation instructions - You can attend follow-up appointments **You may NOT be eligible if:** - You have an active infection - You have poor circulation in your legs - You have osteoporosis or conditions that weaken bones (such as diabetes or rheumatism) - You have significant nerve damage (neuropathy) - You are pregnant - You have complex regional pain syndrome in the foot being operated on - You have a tumor or cancer spread to the lower limb Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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