Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06628336

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Total Hip Replacement

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinique de Franche-Comté, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 pregnant within 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-up visits

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 (severe osteoporosis)
  • 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.

Treatment and study plan

HARMONY EVOLUTION

Device

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

Primary outcomes

  1. Evaluate safety by means of measuring Adverse event recurrences

    Time frame: 2 months, 1, 3, 5 and 10 years follow-up

    Proportion of patients requiring a revision.

  2. Evaluate performance by means of clinical and quality of life scores

    Time frame: 2 months, 1, 3, 5 and 10 years follow-up

    Score PMA > 15 points

Secondary outcomes

  1. Evaluate performance by means of surgeon satisfaction questionnaire

    Time frame: 2 months, 1, 3, 5 and 10 years follow-up

    Evaluate the success of the surgical procedure and evaluate surgeon satisfaction regarding the implant components and the use of instruments with the criteria: very satisfied - satisfied - unsatisfied - very unsatisfied for each surgical step.

Study contacts

Contact information is provided by the study sponsor or research team.

Bojana Gannevat

CONTACT

[email protected]

+41 24 424 26 26

Sponsors and collaborators

Lead sponsor

Symbios Orthopedie SA

Industry

Registry information

Important dates

Study start
2023
Primary completion
2034
Study completion
2035
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.