Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

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

Detailed Description
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Hip arthroplasty<br>Patients with Hip implants. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Evaluation of clinical performance of Corin hip implants | Change of Patient Reported Outcome Measures (PROMs) | 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 | 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 | starting intraoperatively up to 20-year FU | 
| Evaluation of patient quality of life | Improvement of quality of life via EQ-5D-5L scores. | starting intraoperatively up to 20-year FU | 
| Evaluation of patient satisfaction following surgery | Improvement of patient's satisfaction | 3 months ; 2.5-year; 6, 11, 15, 20-year visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Hip Replacement, Acetabular cup, Femoral stem