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A Clinical Study Carried Out in Patients Operated With Calcanail®

NCT ID: NCT06234358

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-01

Brief Summary

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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

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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

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Calcaneus Fracture Calcaneus Deformity of Foot Arthrosis; Localized

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Calcanail cohort

Patients implanted with medical device under study between January 2012 and January 2020.

osteosynthesis

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FH ORTHO

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien LUCAS-HERNANDEZ, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU Pellegrin

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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2017-17

Identifier Type: -

Identifier Source: org_study_id