Calcaneus Fracture Clinical Trial
Official title:
A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device
NCT number | NCT06234358 |
Other study ID # | 2017-17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | February 1, 2023 |
Verified date | January 2024 |
Source | FH ORTHO |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | February 1, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Pellegrin | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
FH ORTHO |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | survival rate (revision) | This objective will be evaluated according to the revision rate in the study | 12 months | |
Secondary | AOFAS score: American Orthopaedic Foot & Ankle Society Score | performance / 100 points represent an "excellent" result and the minimal score was 0 | 12 months | |
Secondary | Bone consolidation | Visible on X-ray after surgery | 4 months | |
Secondary | Emergent adverse event | 12 months |
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