NCT01420237

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

Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Restoration ADM X3 Device	Restoration ADM X3 Device in total hip replacement.

Timeline

• Start date: 2011-06-01
• Primary completion: 2023-11-09
• Completion: 2023-11-09
• First posted: 2011-08-19
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

12 sites across 3 countries: United States, Canada, Germany