NCT06234358

A Clinical Study Carried Out in Patients Operated With Calcanail®

A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Calcaneus Fracture
• Calcaneus Deformity of Foot
• Arthrosis; Localized

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-09-01
• Completion: 2023-02-01
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: France