Clinical trial NCT06628336: Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Official title: Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Hip Replacement
Keywords: HARMONY
THR
Prosthesis
Lead sponsor: Symbios Orthopedie SA
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Evaluate safety by means of measuring Adverse event recurrences
timeFrame: 2 months, 1, 3, 5 and 10 years follow-up
measure: Evaluate performance by means of clinical and quality of life scores
timeFrame: 2 months, 1, 3, 5 and 10 years follow-up
Secondary outcomes:
measure: Evaluate performance by means of surgeon satisfaction questionnaire
timeFrame: 2 months, 1, 3, 5 and 10 years follow-up
Other outcomes:
Locations:
city: Besançon
country: France
facility: Polyclinique de Franche-Comté
city: Grenoble
country: France
facility: Clinique Belledonne
city: Marseille
country: France
facility: Clinique Juge
city: Paris
country: France
facility: Clinique Arago
city: Toulouse
country: France
facility: Médipôle Garonne
Study officials:
affiliation: Clinique Arago
name: Christophe Castelain, Dr.
role: PRINCIPAL_INVESTIGATOR
References: