A Clinical Study Carried Out in Patients Operated With Calcanail®

January 29, 2024 updated by: FH ORTHO

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient operated with the studied device between the 01/01/2012 and 01/01/2020.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Calcanail cohort
Patients implanted with medical device under study between January 2012 and January 2020.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate (revision)
Time Frame: 12 months
This objective will be evaluated according to the revision rate in the study
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS score: American Orthopaedic Foot & Ankle Society Score
Time Frame: 12 months
performance / 100 points represent an "excellent" result and the minimal score was 0
12 months
Bone consolidation
Time Frame: 4 months
Visible on X-ray after surgery
4 months
Emergent adverse event
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FH ORTHO

Investigators

  • Principal Investigator: Julien LUCAS-HERNANDEZ, MD, Chu Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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