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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-11

Study Completion Date

2035-03-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Total Hip Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HARMONY EVOLUTION

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No