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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Harris Hip Score Evaluation
Timeframe: 2 year
2
Number of Participants With Radiologic Failure of Device