Rejuvenate Modular Outcomes Study

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 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.