Post-Market Study of the Modular Revision Hip System (NCT01464645) | Clinical Trial Compass
TerminatedNot Applicable
Post-Market Study of the Modular Revision Hip System
United States16 participantsStarted 2012-01
Plain-language summary
The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be a candidate for revision hip arthroplasty
* Subject must have either poor bone stock or deficiencies of the femoral head, neck or portions of the proximal femur
* Subject's hip joint must be anatomically and functionally suited to receive the hip implant
* Subject must have a body mass index of 40.00 or less (BMI) ≤ 40.00 at time of consent
* Subject must be willing and able to sign the informed consent and follow study procedures
* Subject must be 18 years of age or older (≥ 18) at the time of consent
* Subject must be willing to return for all study visits
* Subject (female) must not be pregnant at time of surgery
Exclusion Criteria:
* Subject must not be receiving a primary hip replacement
* Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject has a condition that places excessive demand on the implant including high levels of physical activity (i.e. competitive sports, heavy physical labor)
* Subject has a BMI \>40.00
* Subject is skeletally immature
* Subject has osteomyelitis
* Subject has loss of ligamentous structures
* Subject is a prisoner
* Subject is pregnant
* Subject has an active in…
What they're measuring
1
Harris Hip Score Evaluation
Timeframe: 2 year
2
Number of Participants With Radiologic Failure of Device