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

NCT ID: NCT01420237

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 367 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2023-11-09

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Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restoration ADM X3 Device

Restoration ADM X3 Device in total hip replacement.

Group Type: OTHER

Restoration ADM X3 Device

Intervention Type: DEVICE

Restoration ADM X3 Device in total hip replacement.

Interventions

Restoration ADM X3 Device

Restoration ADM X3 Device in total hip replacement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
• Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
• Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• Patient is a candidate for a primary cementless acetabular replacement.
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

• Patient has a Body Mass Index (BMI) ≥ 40.
• Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
• Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
• Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
• Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
• Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
• Patient has a known sensitivity to device materials.
• Patient is a prisoner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Hedley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona Institute for Bone & Joint Disorders

Kipling Sharpe, M.D.

Role: PRINCIPAL_INVESTIGATOR

OrthoArizona

Craig J. Della Valle, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Geoffrey Westrich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Joseph Nessler, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Cloud Orthopedic Associates

Brian C de Beaubien, M.D.

Role: PRINCIPAL_INVESTIGATOR

Covenant Medical Center

Christoph Lohmann, MD

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinikum Madgeburg A.o.R.

Paul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Amit Atrey, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Brett Greenky, MD

Role: PRINCIPAL_INVESTIGATOR

Syracuse Orthopedic Specialists

Ajay Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Missouri Orthopaedic Institute

Edward Petrow, DO

Role: PRINCIPAL_INVESTIGATOR

Tucson Orthopaedic Institute

Locations

OrthoArizona

Gilbert, Arizona, United States

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Rush University Medical Center

Chicago, Illinois, United States

Covenant Medical Center

Saginaw, Michigan, United States

St. Cloud Orthopedic Associates

Sartell, Minnesota, United States

Missouri Orthopaedic Institute

Columbia, Missouri, United States

Syracuse Orthopedic Specialists

Fayetteville, New York, United States

Hospital for Special Surgery

New York, New York, United States

The Ottawa Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8

Magdeburg, Saxony-Anhalt, Germany

Countries

United States; Canada; Germany

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

70

Identifier Type: -

Identifier Source: org_study_id