Arthrosis; Localized, Calcaneus Deformity of Foot, Calcaneus Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEosteosynthesis
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.
Sponsors
FH ORTHO
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient operated with the studied device between the 01/01/2012 and 01/01/2020. 2. Patient over 18 years old 3. Patient who has received informed information and does not object to the collection of their data in this study.
Exclusion criteria
Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival rate (revision) | 12 months | This objective will be evaluated according to the revision rate in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS score: American Orthopaedic Foot & Ankle Society Score | 12 months | performance / 100 points represent an excellent result and the minimal score was 0 |
| Bone consolidation | 4 months | Visible on X-ray after surgery |
| Emergent adverse event | 12 months | — |
Countries
France
Outcome results
None listed