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A Clinical Study Carried Out in Patients Operated With Calcanail®

NCT06234358 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • FH ORTHO

    lead INDUSTRY

Principal Investigators

  • Julien LUCAS-HERNANDEZ, MD · University Hospital, Bordeaux

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-09-01
Completion
2023-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06234358 on ClinicalTrials.gov