Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments

Last updated: October 3, 2024
Sponsor: Symbios Orthopedie SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hip Replacement

Treatment

HARMONY EVOLUTION

Clinical Study ID

NCT06628336
CLIN-H-035
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.

The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score > 15 points) & safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).

The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects of 18 years of age and older

  • Each subject who is willing to give informed consent

  • Clinically indicated for a Total Hip Replacement

  • Women of childbearing age who are not pregnant and do not expect to become pregnantwithin 12 months. A pregnancy test should be performed for women of childbearing age

  • Geographically stable and willing to return to the implanting site for all follow-upvisits

Exclusion

Exclusion Criteria:

  • Acute or chronic, local or systemic infection

  • Muscular, neurological, psychological or vascular deficits

  • Poor bone density and quality likely to affect implant stability (severeosteoporosis)

  • Any concomitant condition likely to affect implant integration or function

  • Allergy or hypersensitivity to any of the materials used

Specific:

• The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.

Study Design

Total Participants: 264
Treatment Group(s): 1
Primary Treatment: HARMONY EVOLUTION
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
March 11, 2035

Study Description

The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants.

Patients will be included in the study during 12 months and followed-up during 10 years.

Connect with a study center

  • Polyclinique de Franche-Comté

    Besançon,
    France

    Active - Recruiting

  • Clinique Belledonne

    Grenoble, 38400
    France

    Active - Recruiting

  • Clinique Juge

    Marseille, 13008
    France

    Active - Recruiting

  • Clinique Arago

    Paris, 75014
    France

    Active - Recruiting

  • Médipôle Garonne

    Toulouse, 31100
    France

    Active - Recruiting

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