Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

March 17, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Active, not recruiting
        • CHU de Bordeaux - Groupe hospitalier Pellegrin
      • Cannes, France, 06400
        • Terminated
        • clinique Oxford Cannes
      • Dunkirk, France, 59385
        • Terminated
        • CH Dunkerque
      • Hénin-Beaumont, France, 62254
        • Recruiting
        • Polyclinique Henin Beaumont
        • Contact:
          • Romain GALMICHE, 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
        • Terminated
        • Centre Hospitalier Régionnal d'Orléans - Site La Source
      • Paris, France, 75020
        • Recruiting
        • Hôpital de la Croix Saint-Simon
        • Contact:
          • Antoine MOUTON, MD
        • Principal Investigator:
          • Antoine MOUTON, MD
      • Paris, France, 75014
        • Terminated
        • Clinique Arago
      • Pessac, France, 33600
        • Active, not recruiting
        • Hôpital privé Saint-Martin
      • Roubaix, France, 59100
        • Recruiting
        • Hôpital Provo
        • Contact:
          • François GIRAUD, MD
        • Principal Investigator:
          • François GIRAUD, MD
      • Saint-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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with Hip arthroplasty
Patients with Hip implants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2044

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIPLTO

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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