Post-Market Observational Study of the HARMONY® Evolution... | NCT06628336

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

NCT06628336

Sponsor

Symbios Orthopedie SA

Status

Recruiting

Last Update Posted

Oct 4, 2024Actual

Enrollment

264Estimated

Phase

Not provided

Conditions

Total Hip Replacement

Interventions

HARMONY EVOLUTION

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2023Actual

Primary Completion Date

Oct 11, 2034Estimated

Completion Date

Mar 11, 2035Estimated

First Submitted Date

May 2, 2024

First Submission Date that Met QC Criteria

Oct 3, 2024

First Posted Date

Oct 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2024

Last Update Posted Date

Oct 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

264Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HARMONY EVOLUTION	Device	It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate safety by means of measuring Adverse event recurrences	Proportion of patients requiring a revision.	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	2 months, 1, 3, 5 and 10 years follow-up

Secondary Outcomes

Measure	Description	Time Frame
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.	2 months, 1, 3, 5 and 10 years follow-up

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bojana Gannevat	Contact	+41 24 424 26 26		bojana.gannevat@symbios.ch

Overall Officials

Name	Affiliation	Role
Christophe Castelain, Dr.	Clinique Arago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Polyclinique de Franche-Comté	Recruiting	Besançon			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided