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

Symbios

Status: Enrolling

Conditions: Total Hip Replacement

Treatments: Device: HARMONY EVOLUTION

Study type: Observational

Funder types: Industry

Identifiers

NCT06628336

CLIN-H-035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.