AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Study Overview
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Brief Summary
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This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

Detailed Description
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The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM. 500 patients was the enrollment goal with 2 subgroups. Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements; Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.

Official Title
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Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes

Conditions
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Primary Osteoarthritis, Osteotomies, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture, Femoral Head Necrosis, Sequelae From Previous Hip Surgery, Congenital Hip Dysplasia

Intervention / Treatment
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* Other: Avantage Reload cup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically Primary osteoarthritis Post-Traumatic arthritis Inflammatory joint disease (e.g. Rheumatoid arthritis) Femoral neck fracture Femoral head necrosis Sequelae from previous hip surgery, osteotomies, etc. Congenital hip dysplasia Additional inclusion criteria include: Male or female 18 years of age or older Subjects willing to return for follow-up evaluations Subjects who read, understand study information and give written consent (specific local regulatory requirements) Exclusion Criteria: Exclusion criteria should be in accordance with Contraindications for the AVANTAGE® RELOAD: Absolute contraindications include: Infection Sepsis Severe muscular, neurological or vascular deficiencies of the extremity involved Bone destruction or poor bone quality Additional contraindications include: Subjects unable to co-operate with and complete the study Dementia and inability to understand and follow instructions Neurological conditions affecting movement Patient over 18 under law supervision

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subgroup 1<br>Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD | Other: Avantage Reload cup<br>* Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty<br>|
| Other: Subgroup 2<br>Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner | Other: Avantage Reload cup<br>* Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | Implant survivorship | 10 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip scores | To measure clinical efficacy | 10 years post-surgery | 
| EQ-5D | To measure clinical efficacy | 10 years post-surgery | 
| Radiographic Evaluation | Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc) | 10 years post-surgery | 
| Complications | Eventual complications occurred including dislocations and revisions/removals | 10 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip Arthroplasty, Hip implant