Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02230826

Enrollment

2500

Registered

2014-09-03

Start date

2014-05-01

Completion date

2044-12-01

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Arthroplasty, Hip Replacement, Acetabular cup, Femoral stem

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 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
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 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

Countries

France

Contacts

CONTACTVanessa Grimaud

vanessa.grimaud@coringroup.com

STUDY_CHAIRGoulven Rochcongar, MD

University Hospital, Caen

Outcome results