A Clinical Study Carried Out in Patients Operated With Calcanail®

Completed

• Conditions: Calcaneus Deformity of Foot; Arthrosis; Localized; Calcaneus Fracture
• Interventions: Device: osteosynthesis

• Registration Number: NCT06234358
• Lead Sponsor: FH ORTHO

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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-02-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calcanail cohort	osteosynthesis	Patients implanted with medical device under study between January 2012 and January 2020.

Primary Outcome Measures

Name	Time	Method
survival rate (revision)	12 months	This objective will be evaluated according to the revision rate in the study

Secondary Outcome Measures

Name	Time	Method
Emergent adverse event	12 months
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

Trial Locations

Locations (1)

CHU Pellegrin; 🇫🇷 Bordeaux, France