Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Recruiting

• Conditions: Congenital Dislocations; Hip Replacement; Primary, Secondary or Post-traumatic Osteoarthrosis; Femur Head Necrosis; Primary and Revision Surgery

• Registration Number: NCT02230826
• Lead Sponsor: Corin

Brief Summary

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

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2034-12
• Study Completion: 2044-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of long-term outcome after hip arthroplasty with Corin implants.	At 10 years	Implants revision rate at 10-year FU hip arthroplasty

Secondary Outcome Measures

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

Trial Locations

Locations (13)

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, France