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

Symbios Orthopedie SA264 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

264

Conditions

Total Hip Replacement

Interventions

HARMONY EVOLUTIONDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (5)

Polyclinique de Franche-Comté

Besançon, France

RECRUITING

Clinique Belledonne

Grenoble, France

RECRUITING

Clinique Juge

Marseille, France

RECRUITING

Clinique Arago

Paris, France

RECRUITING

Médipôle Garonne

Toulouse, France

RECRUITING

Outcomes

Primary Outcomes

Evaluate safety by means of measuring Adverse event recurrences

Proportion of patients requiring a revision.

Time frame: 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

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

Secondary Outcomes

Evaluate performance by means of surgeon satisfaction questionnaire

Evaluate the success of the surgical procedure and evaluate surgeon satisfaction regarding the implant components and the use of instruments with the criteria: very satisfied - satisfied - unsatisfied - very unsatisfied for each surgical step.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts