Observational Ambispective Study on HYPE Cups Associated... | NCT06465940

Studies
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

NCT06465940

Sponsor

Societe dEtude, de Recherche et de Fabrication

Status

Completed

Last Update Posted

Jun 20, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Hip Arthropathy

Interventions

Total hip arthroplasty

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2020Actual

Primary Completion Date

Jul 7, 2020Actual

Completion Date

Jul 7, 2020Actual

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 14, 2024

First Posted Date

Jun 20, 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

Jun 14, 2024

Last Update Posted Date

Jun 20, 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

This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.

Detailed Description

Not provided

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

23Actual

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty	Device	Replacement of hip joint

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional score	The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation	per operative period to at least 2 year

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	The information will be collected from patient through questionnaires to compare preoperatively situation to last follow-up situation	per operative period to at least 2 year
Safety adverse event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient was an adult at surgery,
Patient implanted with HYPE® acetabular cup and HIPER liner,
Patient was followed-up at least once on retrospective part of the study,
Patient's current social security affiliation is valid.

Exclusion Criteria:

Patient refuses the use of his/her personal data,
Patient is unable to follow surgeon's instruction or unavailable for follow-up,
Patient with contraindication to x-rays,
Patient not implanted with HYPE® acetabular cup and HIPER liner.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient implanted in the selected investigational site with a HYPE® acetabular cup and HIPER liner between 2016 and 2018 were identified. The following selection criteria were used.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de la Côte Basque		Bayonne		64109	France

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided