A Clinical Study Carried Out in Patients Operated With Calcanail®

NCT06234358 | Completed

• 1 other identifier: 2017-17
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• survival rate (revision)

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

  12 months

Secondary Outcomes (3)

• AOFAS score: American Orthopaedic Foot & Ankle Society Score

  12 months

• Bone consolidation

  4 months

• Emergent adverse event

  12 months

Study Arms (1)

Calcanail cohort

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

Device: osteosynthesis

Interventions

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.

Calcanail cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.

Sponsors & Collaborators

• FH ORTHO: lead

Study Sites (1)

CHU Pellegrin

Bordeaux, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Julien LUCAS-HERNANDEZ, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 31, 2024
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: February 1, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)