Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

June 14, 2024 updated by: Societe dEtude, de Recherche et de Fabrication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayonne, France, 64109
        • Centre Hospitalier de la Côte Basque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional score
Time Frame: per operative period to at least 2 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: per operative period to at least 2 year
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
Time Frame: per operative period to at least 2 year
Type and occurence of adverse events
per operative period to at least 2 year
Survival rate
Time Frame: per operative period to at least 2 year
Kaplan-Meier survival rates of cups and liners
per operative period to at least 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societe dEtude, de Recherche et de Fabrication

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2020

Primary Completion (Actual)

July 7, 2020

Study Completion (Actual)

July 7, 2020

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Arthropathy

Clinical Trials on Total hip arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe