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



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:6/21/2017
Start Date:June 2011
End Date:June 2026

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

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.


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.
We found this trial at
10
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1100 Virginia Avenue
Columbia, Missouri 65212
Principal Investigator: Ajay Aggarwal, MD
Phone: 573-882-7615
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Columbia, MO
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4115 Medical Center Drive
Fayetteville, New York 13066
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Fayetteville, NY
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Gilbert, Arizona 85234
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Gilbert, AZ
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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1967 Riverside Drive
Ottawa, Ontario K1H 7W9
Principal Investigator: Paul Kim, MD
Phone: 613-737-8899
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Ottawa,
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Phoenix, AZ
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Saginaw, Michigan 48602
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Saginaw, MI
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Sartell, Minnesota 56377
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Sartell, MN
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Tucson, Arizona 85713
Principal Investigator: Russell Cohen, MD
Phone: 520-784-6141
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Tucson, AZ
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