Rejuvenate Modular Hip
DeviceRejuvenate Modular Hip
NCT Number: NCT01257568
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Oakwood Healthcare, Dearborn, Michigan, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rejuvenate Modular Hip
Time frame: 5 years postoperative
The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.
Time frame: 6 weeks
Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Stryker Orthopaedics
Industry
A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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