Condition: Medial Malleolus Fracture · Lisfranc Injury · Lisfranc Fracture · Sponsor: Inion Oy
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.
This description comes directly from the study's public registry record.
Marika Manni, MD · +358 50 366 9994 · marika.manni@inion.com
Kati Marttinen · +358 40 841 6217 · kati.marttinen@inion.com
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| Tampere University Hospital | Tampere, Finland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05555459