Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Corin2,500 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

2,500

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

CHU de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, France

ACTIVE_NOT_RECRUITING

clinique Oxford Cannes

Cannes, France

TERMINATED

Outcomes

Primary Outcomes

Evaluation of long-term outcome after hip arthroplasty with Corin implants.

Implants revision rate at 10-year FU hip arthroplasty

Time frame: At 10 years

Secondary Outcomes

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.

Time frame: at 15- and 20-year

Evaluation of clinical performance of Corin hip implants

Change of Patient Reported Outcome Measures (PROMs)

Time frame: starting intraoperatively up to 20-year FU

Evaluation of Safety of Corin hip implants

Number, severity and causal relationship of procedure or implant-related Adverse Events

Time frame: starting intraoperatively up to 20-year FU

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

Time frame: starting intraoperatively up to 20-year FU

Evaluation of patient quality of life

Improvement of quality of life via EQ-5D-5L scores.

Time frame: starting intraoperatively up to 20-year FU

Evaluation of patient satisfaction following surgery

Improvement of patient's satisfaction

Time frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits

Central Contacts

Vanessa Grimaud

CONTACT

vanessa.grimaud@coringroup.com

Data from ClinicalTrials.gov

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