Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02230826
• Other study ID #: 1302-T-HIPLTO-RM
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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