This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market. The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device. This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national. 84 patients will be included in the study.
The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.
Study Type
OBSERVATIONAL
Enrollment
84
calcaneus osteosynthesis is a surgical fixation of a displaced fracture of the calcaneous bone. The surgery is performed under general or regional anesthesia. A scar is made on the lateral side of the ankle below the lateral malleolus. The bone fragments are repositioned as anatomically as possible. They are fixed by a percutaneous nailing fastener.
CHU Pellegrin
Bordeaux, France
survival rate (revision)
This objective will be evaluated according to the revision rate in the study
Time frame: 12 months
AOFAS score: American Orthopaedic Foot & Ankle Society Score
performance / 100 points represent an "excellent" result and the minimal score was 0
Time frame: 12 months
Bone consolidation
Visible on X-ray after surgery
Time frame: 4 months
Emergent adverse event
Time frame: 12 months
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