Total Hip Replacement
Conditions
Keywords
HARMONY, THR, Prosthesis
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.
Interventions
DEVICEHARMONY EVOLUTION
It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.
Sponsors
Symbios Orthopedie SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety by means of measuring Adverse event recurrences | 2 months, 1, 3, 5 and 10 years follow-up | Proportion of patients requiring a revision. |
| Evaluate performance by means of clinical and quality of life scores | 2 months, 1, 3, 5 and 10 years follow-up | Score PMA \> 15 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate performance by means of surgeon satisfaction questionnaire | 2 months, 1, 3, 5 and 10 years follow-up | 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. |
Countries
France
Contacts
Primary ContactBojana Gannevat
Outcome results
None listed