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

Corin25 sites in 1 country2,500 target enrollmentMay 1, 2014

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

Overview

Phase: Not Applicable
Intervention: Patients with Hip arthroplasty
Conditions: Hip Replacement
Sponsor: Corin
Enrollment: 2500
Locations: 25
Primary Endpoint: Evaluation of long-term outcome after hip arthroplasty with Corin implants.
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2014

End Date

December 1, 2044

Last Updated

last month

Study Type

Observational

Sex

All

Investigators

Sponsor

Corin

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Patients with Hip arthroplasty

Patients with Hip implants.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Evaluation of patient quality of life(starting intraoperatively up to 20-year FU)
Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.(at 15- and 20-year)
Evaluation of patient satisfaction following surgery(3 months ; 2.5-year; 6, 11, 15, 20-year visits)
Radiological evaluation of positioning and osteointegration of Corin hip implants.(starting intraoperatively up to 20-year FU)
Evaluation of clinical performance of Corin hip implants(starting intraoperatively up to 20-year FU)
Evaluation of Safety of Corin hip implants(starting intraoperatively up to 20-year FU)