Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.

Clinical Trial Description

This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component. Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references. ;

Study Design

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT01420237
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 2011
Completion date	June 2026

View Details

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