Rejuvenate Modular Outcomes Study

Not Applicable

Completed

Conditions: Arthroplasty, Replacement, Hip

Interventions: Device: Rejuvenate Modular Hip

Registration Number: NCT01257568

Lead Sponsor: Stryker Orthopaedics

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rejuvenate Modular Hip System	Rejuvenate Modular Hip	Rejuvenate Modular Hip

Primary Outcome Measures

Name	Time	Method
Survival Rate of the Rejuvenate Modular Stem/Neck	5 years postoperative	The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.

Secondary Outcome Measures

Name	Time	Method
Biomechanical Measurement of Femoral Offset	6 weeks	Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.
Mean SF-12 Scores at Each Visit	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year	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.
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)	6 wks,1,2,3,4,5 yrs	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.
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation	6 weeks	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.
Mean Harris Hip Score at Each Visit	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year	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
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year	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.
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation	6 weeks	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.

Trial Locations

Locations (3): Oakwood Healthcare
🇺🇸
Dearborn, Michigan, United States
The Orthopedic Center
🇺🇸
Tulsa, Oklahoma, United States
St. Cloud Orthopaedics Associates
🇺🇸
Sartell, Minnesota, United States