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 |
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.
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
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
Columbia, Missouri 65212
Principal Investigator: Ajay Aggarwal, MD
Phone: 573-882-7615
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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
Ottawa, Ontario K1H 7W9
Principal Investigator: Paul Kim, MD
Phone: 613-737-8899
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Tucson, Arizona 85713
Principal Investigator: Russell Cohen, MD
Phone: 520-784-6141
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