Restoration Anatomic Acetabular Shell Revision Study

Study Overview
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Brief Summary
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This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.

Official Title
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Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication

Conditions
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Arthropathy, Hip Arthropathy, Hip Osteoarthritis

Intervention / Treatment
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* Device: Restoration Anatomic Acetabular Shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell. Subject has signed an IRB-approved, study specific Informed Consent Form (ICF). Subject is skeletally mature. Subject is a male or non-pregnant female. Subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: Subject has a non-Stryker retained stem at the time of study device implantation. Subject has a Body Mass Index (BMI) > 45. Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days). Subject has a known sensitivity to device materials. Subject is a prisoner.
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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restoration Anatomic Acetabular Shell<br> | Device: Restoration Anatomic Acetabular Shell<br>* Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Success rate is defined as no incidence of revision for aseptic loosening | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | All protocol defined adverse events as well as all-cause revision and/or removal of RAS | 10 years |