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

NCT06628336 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 264

Last updated 2024-10-04

No results posted yet for this 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.

Conditions

  • Total Hip Replacement

Interventions

DEVICE

HARMONY EVOLUTION

It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.

Sponsors & Collaborators

  • Symbios Orthopedie SA

    lead INDUSTRY

Principal Investigators

  • Christophe Castelain, Dr. · Clinique Arago

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2034-10-11
Completion
2035-03-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628336 on ClinicalTrials.gov