A Clinical Study Carried Out in Patients Operated With Calcanail®

F

FH ORTHO

Status

Completed

Conditions

Arthrosis; Localized
Calcaneus Deformity of Foot
Calcaneus Fracture

Treatments

Device: osteosynthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT06234358
2017-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

84 participants in 1 patient group

Calcanail cohort
Description:
Patients implanted with medical device under study between January 2012 and January 2020.
Treatment:
Device: osteosynthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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