Research

A Prospective Study of the Restoration Anatomic Dual Mobility (ADM) X3 Acetabular System

IRB Number: 11116

Institutional Review Board, Hospital for Special Surgery

August 22, 2011

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Geoffrey H. Westrich, MD

Co-Investigators

Natalie Parkes

Summary

350 patients from up to 12 centers, 24 month enrollment period, follow-up to 10 years

Inclusion/Exclusion Criteria

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

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

Contact Information

Geoffrey H. Westrich, MD,
westrichg@hss.edu
212.606.1510

Natalie Parkes
parkesn@hss.edu
212.774.7513



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