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NCT02230826 | RECRUITING | Hip Replacement

Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
Sponsor:

Corin

Brief Summary:

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

Condition or disease

Hip Replacement

Primary, Secondary or Post-traumatic Osteoarthrosis

Femur Head Necrosis

Congenital Dislocations

Primary and Revision Surgery

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
Estimated Enrollment : 2500 participants
Official Title : Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
Actual Study Start Date : 2014-05
Estimated Primary Completion Date : 2034-12
Estimated Study Completion Date : 2044-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Location Details

NCT02230826

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

France,

Bordeaux University Hospital - Pellegrin Hospital Group

Bordeaux, France, 33000

TERMINATED

France,

clinique Oxford Cannes

Cannes, France, 06400

TERMINATED

France,

CH Dunkirk

Dunkirk, France, 59385

RECRUITING

France,

Henin Beaumont Polyclinic

Hénin-Beaumont, France, 62254

RECRUITING

France,

chu's nice

Nice, France, 06000

TERMINATED

France,

Orléans Regional Hospital Center - La Source Site

Orléans, France, 45000

RECRUITING

France,

Arago Clinic

Paris, France, 75014

RECRUITING

France,

Croix Saint-Simon Hospital

Paris, France, 75020

ACTIVE NOT RECRUITING

France,

Saint-Martin private hospital

Pessac, France, 33600

RECRUITING

France,

Provo Hospital

Roubaix, France, 59100

RECRUITING

France,

St Georges de Didonne Polyclinic

St George of Didonne, France, 17110

TERMINATED

France,

Médipôle Garonne

Toulouse, France, 31000

RECRUITING

France,

Jean Bernard Hospital

Valenciennes, France, 59300