Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

Last updated: August 26, 2024
Sponsor: Dedienne Sante S.A.S.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

Total hip arthroplasty (primary or revision)

Clinical Study ID

NCT05227924
PMCF_SYMBOL_01
  • Ages > 18
  • All Genders

Study Summary

The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient age > 18 years at implantation.

  • Patient who will undergo, during the study's period of inclusion, a total hiparthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNESanté).

  • Patient informed of his/her participation and willing to participate in the study.

  • Patient able to read, write and understand French.

Exclusion

Exclusion Criteria:

  • Patient deprived of freedom, under guardianship/curatorship or placed under judicialprotection

  • Patient unable to follow study procedures.

  • Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.

Study Design

Total Participants: 747
Treatment Group(s): 1
Primary Treatment: Total hip arthroplasty (primary or revision)
Phase:
Study Start date:
September 21, 2021
Estimated Completion Date:
September 30, 2034

Connect with a study center

  • Hôpital Privé de la Châtaigneraie

    Beaumont, 63110
    France

    Active - Recruiting

  • CH de Marmande - CHIC

    Marmande, 47207
    France

    Terminated

  • CH du Forez

    Montbrison, 42600
    France

    Site Not Available

  • Hôpital Privé du Grand Narbonne

    Montredon-des-Corbières, 11100
    France

    Active - Recruiting

  • Polyclinique Grand Sud

    Nîmes, 30932
    France

    Active - Recruiting

  • Clinique Mutualiste Catalane

    Perpignan, 66140
    France

    Active - Recruiting

  • CH de Péronne

    Péronne, 80200
    France

    Active - Recruiting

  • Clinique Mutualiste

    Saint-Étienne, 83000
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Saint-Anne

    Toulon, 83000
    France

    Active - Recruiting

  • Hôpital Robert Schuman - UNEOS

    Vantoux, 57070
    France

    Active - Recruiting

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