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Completed

NCT Number: NCT06234358

A Clinical Study Carried Out in Patients Operated With Calcanail®

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.

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Key information

Conditions

Calcaneus Fracture Arthritis Arthrosis; Localized Calcaneus Deformity of Foot Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Pellegrin

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
  • Patient over 18 years old
  • 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.

Treatment and study plan

osteosynthesis

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.

Primary outcomes

  1. survival rate (revision)

    Time frame: 12 months

    This objective will be evaluated according to the revision rate in the study

Secondary outcomes

  1. 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

  2. Bone consolidation

    Time frame: 4 months

    Visible on X-ray after surgery

  3. Emergent adverse event

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

FH ORTHO

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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