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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02230826
Other study ID # 1302-T-HIPLTO-RM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2014
Est. completion date December 2044

Study information

Verified date March 2023
Source Corin
Contact Vanessa Grimaud
Email vanessa.grimaud@coringroup.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date December 2044
Est. primary completion date December 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux
France clinique Oxford Cannes Cannes
France CH Dunkerque Dunkerque
France Polyclinique Henin Beaumont Hénin-Beaumont
France CHU de Nice Nice
France Centre Hospitalier Régionnal d'Orléans - Site La Source Orléans
France Clinique Arago Paris
France Hôpital de la Croix Saint-Simon Paris
France Hopital privé Saint-Martin Pessac
France Hôpital Provo Roubaix
France Polyclinique St Georges de Didonne St Georges de Didonne
France Médipôle Garonne Toulouse
France Hôpital Jean Bernard Valenciennes

Sponsors (1)

Lead Sponsor Collaborator
Corin

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of long-term outcome after hip arthroplasty with Corin implants. Implants revision rate at 10-year FU hip arthroplasty At 10 years
Secondary Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU. Implants revision rate at 15- and 20-year FU. at 15- and 20-year
Secondary Evaluation of clinical performance of Corin hip implants Change of Patient Reported Outcome Measures (PROMs) starting intraoperatively up to 20-year FU
Secondary Evaluation of Safety of Corin hip implants Number, severity and causal relationship of procedure or implant-related Adverse Events starting intraoperatively up to 20-year FU
Secondary Radiological evaluation of positioning and osteointegration of Corin hip implants. Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation starting intraoperatively up to 20-year FU
Secondary Evaluation of patient quality of life Improvement of quality of life via EQ-5D-5L scores. starting intraoperatively up to 20-year FU
Secondary Evaluation of patient satisfaction following surgery Improvement of patient's satisfaction 3 months ; 2.5-year; 6, 11, 15, 20-year visits
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