Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Recruiting
N/A
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 125 (estimated)
- Sponsor
- Inion Oy · Industry
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About This Trial
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…
Trial Locations
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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 …
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