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

October 3, 2024 updated by: Symbios Orthopedie SA

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • Polyclinique de Franche-Comté
        • Contact:
      • Grenoble, France, 38400
      • Marseille, France, 13008
        • Recruiting
        • Clinique Juge
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Clinique Arago
        • Contact:
      • Toulouse, France, 31100
        • Recruiting
        • Médipôle Garonne
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months, 1, 3, 5 and 10 years follow-up
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
2 months, 1, 3, 5 and 10 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months, 1, 3, 5 and 10 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symbios Orthopedie SA

Investigators

  • Principal Investigator: Christophe Castelain, Dr., Clinique Arago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

October 11, 2034

Study Completion (Estimated)

March 11, 2035

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLIN-H-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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