A Clinical Study Carried Out in Patients Operated With Calcanail®

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06234358
• Other study ID #: 2017-17
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2024
• Source: FH ORTHO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Calcaneus Deformity of Foot
• Calcaneus Fracture
• Foot Deformities
• Osteoarthritis

Intervention

Device:
• osteosynthesis
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.

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
FH ORTHO

Country where clinical trial is conducted

France, 

Outcome

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