Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

March 14, 2023 updated by: Corin

Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty

This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Active, not recruiting
        • CHU de Bordeaux - Groupe hospitalier Pellegrin
      • Cannes, France, 06400
        • Recruiting
        • clinique Oxford Cannes
        • Contact:
          • Mathieu NICOLAS, MD
        • Principal Investigator:
          • Mathieu NICOLAS, MD
      • Dunkerque, France, 59385
        • Not yet recruiting
        • Ch Dunkerque
        • Contact:
          • Nicolas JAN, MD
        • Principal Investigator:
          • Nicolas JAN, MD
      • Hénin-Beaumont, France, 62254
        • Recruiting
        • Polyclinique Henin Beaumont
        • Contact:
          • Pierre CHOLEWINSKI, MD
        • Contact:
          • Romain GALMICHE, MD
        • Principal Investigator:
          • Pierre CHOLEWINSKI, MD
        • Principal Investigator:
          • Romain GALMICHE, MD
      • Nice, France, 06000
        • Recruiting
        • Chu de Nice
        • Contact:
          • Régis BERNARD DE DOMPSURE, MD
        • Principal Investigator:
          • Régis BERNARD DE DOMPSURE, MD
        • Principal Investigator:
          • Jean-François GONZALEZ, MD,PhD
      • Orléans, France, 45000
        • Active, not recruiting
        • Centre Hospitalier Régionnal d'Orléans - Site La Source
      • Paris, France, 75014
        • Recruiting
        • Clinique Arago
        • Contact:
          • Dorick PASSERON, MD
        • Principal Investigator:
          • Dorick PASSERON, MD
      • Paris, France, 75020
        • Recruiting
        • Hôpital de la Croix Saint-Simon
        • Contact:
          • Antoine MOUTON, MD
        • Principal Investigator:
          • Antoine MOUTON, MD
        • Principal Investigator:
          • Luc LHOTELLIER, MD
      • Pessac, France, 33600
        • Active, not recruiting
        • Hôpital Privé Saint-Martin
      • Roubaix, France, 59100
        • Not yet recruiting
        • Hôpital Provo
        • Contact:
          • François GIRAUD, MD
        • Principal Investigator:
          • François GIRAUD, MD
      • St Georges de Didonne, France, 17110
        • Recruiting
        • Polyclinique St Georges de Didonne
        • Contact:
          • Christine LAUTRIDOU, MD
        • Principal Investigator:
          • Christine LAUTRIDOU, MD
      • Toulouse, France, 31000
        • Terminated
        • Médipôle Garonne
      • Valenciennes, France, 59300
        • Recruiting
        • Hopital Jean Bernard
        • Contact:
          • Charles BERTON, MD
        • Principal Investigator:
          • Charles BERTON, MD
        • Sub-Investigator:
          • Alexandre BLAIRON, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort of patients with a partial or total hip replacement (Corin implants)

Description

Inclusion Criteria:

  • Man or woman >18 years
  • Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
  • Subjects who agreed for study participation.

Exclusion Criteria:

  • Subjects with existing tumour and/or particularly high surgical risk-
  • Subjects with anaesthetic risk class IV or higher
  • Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
  • Contraindications for arthroplasty with a Corin hip devices as per product IFU

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with Hip arthroplasty
Patients with Hip implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of long-term outcome after hip arthroplasty with Corin implants.
Time Frame: At 10 years
Implants revision rate at 10-year FU hip arthroplasty
At 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.
Time Frame: at 15- and 20-year
Implants revision rate at 15- and 20-year FU.
at 15- and 20-year
Evaluation of clinical performance of Corin hip implants
Time Frame: starting intraoperatively up to 20-year FU
Change of Patient Reported Outcome Measures (PROMs)
starting intraoperatively up to 20-year FU
Evaluation of Safety of Corin hip implants
Time Frame: starting intraoperatively up to 20-year FU
Number, severity and causal relationship of procedure or implant-related Adverse Events
starting intraoperatively up to 20-year FU
Radiological evaluation of positioning and osteointegration of Corin hip implants.
Time Frame: starting intraoperatively up to 20-year FU
Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation
starting intraoperatively up to 20-year FU
Evaluation of patient quality of life
Time Frame: starting intraoperatively up to 20-year FU
Improvement of quality of life via EQ-5D-5L scores.
starting intraoperatively up to 20-year FU
Evaluation of patient satisfaction following surgery
Time Frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits
Improvement of patient's satisfaction
3 months ; 2.5-year; 6, 11, 15, 20-year visits

Collaborators and Investigators

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

Sponsor

Corin

Investigators

  • Study Chair: Goulven Rochcongar, MD, University Hospital, Caen

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

May 1, 2014

Primary Completion (Anticipated)

December 1, 2034

Study Completion (Anticipated)

December 1, 2044

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1302-T-HIPLTO-RM

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.

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