Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

NCT ID: NCT06465940

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-03

Study Completion Date

2020-07-07

Brief Summary

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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

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Conditions

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Hip Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Total hip arthroplasty

Replacement of hip joint

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societe dEtude, de Recherche et de Fabrication

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de la Côte Basque

Bayonne, , France

Site Status

Countries

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France

Other Identifiers

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2020-05

Identifier Type: -

Identifier Source: org_study_id

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