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

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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

DEVICE

Restoration ADM X3 Device

Restoration ADM X3 Device in total hip replacement.

Sponsors & Collaborators

• Stryker Orthopaedics

  lead INDUSTRY

Principal Investigators

• Anthony Hedley, M.D. · Arizona Institute for Bone & Joint Disorders

• Kipling Sharpe, M.D. · OrthoArizona

• Craig J. Della Valle, M.D. · Rush University Medical Center

• Geoffrey Westrich, M.D. · Hospital for Special Surgery, New York

• Joseph Nessler, M.D. · St. Cloud Orthopedic Associates

• Brian C de Beaubien, M.D. · Covenant Medical Center

• Christoph Lohmann, MD · Universitatsklinikum Madgeburg A.o.R.

• Paul Kim, MD · The Ottawa Hospital

• Amit Atrey, MD · Unity Health Toronto

• Brett Greenky, MD · Syracuse Orthopedic Specialists

• Ajay Aggarwal, MD · Missouri Orthopaedic Institute

• Edward Petrow, DO · Tucson Orthopaedic Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2023-11-09

Completion

2023-11-09

Countries

• United States
• Canada
• Germany

Study Locations