RecruitingNot ApplicableNCT05591859

Restoration Anatomic Acetabular Shell Revision Study

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

Sponsor

Stryker Orthopaedics

Enrollment

56 participants

Start Date

Mar 2, 2024

Study Type

INTERVENTIONAL

Conditions

Arthropathy Hip Arthropathy

Summary

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.

Eligibility

Inclusion Criteria5

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 Criteria9

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.

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Interventions

DEVICERestoration Anatomic Acetabular Shell

Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.