Rejuvenate Modular Outcomes Study

Status:Active, not recruiting
Therapuetic Areas:Orthopedics / Podiatry
Age Range:18 - Any
Start Date:November 2010
End Date:December 2021

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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.

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

- 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.
We found this trial at
Dearborn, Michigan 48124
Dearborn, MI
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Sartell, Minnesota 56377
Sartell, MN
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Tulsa, Oklahoma 74104
Tulsa, OK
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