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

NCT06628336 | Recruiting

• 1 other identifier: CLIN-H-035
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

HARMONY; THR; Prosthesis

Outcome Measures

Primary Outcomes (2)

• Evaluate safety by means of measuring Adverse event recurrences

  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

  Score PMA \> 15 points

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

Secondary Outcomes (1)

• Evaluate performance by means of surgeon satisfaction questionnaire

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

Interventions

HARMONY EVOLUTION DEVICE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Symbios Orthopedie SA: lead

Study Sites (5)

Polyclinique de Franche-Comté

Besançon, France

RECRUITING

Clinique Belledonne

Grenoble, 38400, France

RECRUITING

Clinique Juge

Marseille, 13008, France

RECRUITING

Clinique Arago

Paris, 75014, France

RECRUITING

Médipôle Garonne

Toulouse, 31100, France

RECRUITING

Study Officials

• Christophe Castelain, Dr.

  Clinique Arago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bojana Gannevat

CONTACT

+41 24 424 26 26; bojana.gannevat@symbios.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: October 4, 2024
• Study Start: October 11, 2023
• Primary Completion (Estimated): October 11, 2034
• Study Completion (Estimated): March 11, 2035
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)