Status:
TERMINATED
Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18-75 years
Phase:
NA
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 literatu...
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2023
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT01420237
Start Date
June 1 2011
End Date
November 9 2023
Last Update
January 22 2025
Active Locations (12)
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1
OrthoArizona
Gilbert, Arizona, United States, 85234
2
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona, United States, 85016
3
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
4
Rush University Medical Center
Chicago, Illinois, United States, 60612