Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
ConditionTotal Hip Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSymbios Orthopedie SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Subjects who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HARMONY EVOLUTION
DeviceIt is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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-up2
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-upSecondary outcomes
1
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov