Rejuvenate Modular Outcomes Study
Status: | Active, not recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/26/2019 |
Start Date: | November 2010 |
End Date: | December 2021 |
A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
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 eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years
and clinical outcomes for up to 10 years after surgery.
replacement (THR) with a cementless application in a consecutive series of patients who meet
the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years
and clinical outcomes for up to 10 years after surgery.
Inclusion Criteria:
- 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 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.
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