Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HARMONY EVOLUTION.
- Who it may be relevant to
- Registry conditions: Total Hip Replacement. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Device HARMONY EVOLUTION
It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.
Primary outcome measures
- Evaluate safety by means of measuring Adverse event recurrences [Time frame: 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]
Secondary outcome measures (1)
- Evaluate performance by means of surgeon satisfaction questionnaire [Time frame: 2 months, 1, 3, 5 and 10 years follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 5 centers
- Polyclinique de Franche-Comté — Besançon
- Clinique Belledonne — Grenoble
- Clinique Juge — Marseille
- Clinique Arago — Paris
- Médipôle Garonne — Toulouse
Identifiers
NCT: NCT06628336 · CLIN-H-035