Status:
COMPLETED
Rejuvenate Modular Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibilit...
Eligibility Criteria
Inclusion
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for a primary cementless total hip replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.
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 :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01257568
Start Date
November 1 2010
End Date
January 20 2022
Last Update
February 16 2022
Active Locations (3)
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1
Oakwood Healthcare
Dearborn, Michigan, United States, 48124
2
St. Cloud Orthopaedics Associates
Sartell, Minnesota, United States, 56377
3
The Orthopedic Center
Tulsa, Oklahoma, United States, 74104