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

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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.

Key facts

Study ID

NCT01420237

Run by

Stryker Orthopaedics

People needed

367

Starts

2011-06-01

Expected to finish

2023-11-09

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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