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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcanail cohort | Patients implanted with medical device under study between January 2012 and January 2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osteosynthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| survival rate (revision) | This objective will be evaluated according to the revision rate in the study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| AOFAS score: American Orthopaedic Foot & Ankle Society Score | performance / 100 points represent an "excellent" result and the minimal score was 0 | 12 months |
| Bone consolidation | Visible on X-ray after surgery |
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Inclusion Criteria:
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.
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Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
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| Name | Affiliation | Role |
|---|---|---|
| Julien LUCAS-HERNANDEZ, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pellegrin | Bordeaux | France |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
| 4 months |
| Emergent adverse event | 12 months |