Rejuvenate Modular Outcomes Study

Stryker Orthopaedics42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthroplasty, Replacement, Hip

Interventions

Rejuvenate Modular HipDEVICE

Rejuvenate Modular Hip

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Oakwood Healthcare

Dearborn, Michigan, United States

St. Cloud Orthopaedics Associates

Sartell, Minnesota, United States

The Orthopedic Center

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years postoperative

Secondary Outcomes

Biomechanical Measurement of Femoral Offset

Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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