Rejuvenate Modular Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Rejuvenate Modular Hip


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rejuvenate Modular Hip System<br>Rejuvenate Modular Hip | Device: Rejuvenate Modular Hip<br>* Rejuvenate Modular Hip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate of the Rejuvenate Modular Stem/Neck | The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason. | 5 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanical Measurement of Femoral Offset | Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters. | 6 weeks | 
| Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation | Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters. | 6 weeks | 
| Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation | Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters. | 6 weeks | 
| Mean Harris Hip Score at Each Visit | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | 
| Mean SF-12 Scores at Each Visit | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | 
| Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | 
| Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability of the stem is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative. | 6 wks,1,2,3,4,5 yrs |