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

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

Plain Language Summary

Simplified for easier understanding

This study follows patients who are having a revision hip replacement surgery using a specific implant called the Restoration Anatomic Acetabular Shell. Revision surgery is performed when a previous hip replacement has failed and needs to be replaced. Researchers want to track how well this implant performs over time. You may be eligible if: - You need revision surgery to replace a failed hip socket (acetabular component) - You are skeletally mature (your bones have finished growing) - You are male or non-pregnant female - You are willing to attend follow-up visits after surgery You may NOT be eligible if: - Your retained hip stem is not a Stryker brand - Your BMI is above 45 - You have an active or suspected infection in or around the hip joint - You have a mental or neuromuscular disorder that creates risk for the implant - You have severely compromised bone stock - You have a systemic disease causing bone deterioration (e.g., lupus, Paget's disease) - You are immunosuppressed or taking long-term high-dose steroids - You have a known sensitivity to the implant materials - You are currently incarcerated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Regents of the University of Colorado

Denver, Colorado, United States

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NCT05591859


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