Status:
TERMINATED
Post-Market Study of the Modular Revision Hip System
Lead Sponsor:
Encore Medical, L.P.
Collaborating Sponsors:
DJO Incorporated
Conditions:
Aseptic Loosening
Osteolysis
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
The main goal of Revision Total Hip Arthroplasty (THA) is to restore the patient's hip function by repairing the patient's kinematics. However, a revision hip surgery represents a challenge for even t...
Eligibility Criteria
Inclusion
- 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
- 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 infection or sepsis at time of surgery
- Subject has a history of alcoholism or other addictions (current)
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
- Subject has known materials sensitivity (to metals)
- Subject has a physical condition that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant
- Subject is unwilling to modify post-operative physical activities
- Subject is younger than 18 years of age (\<18) at the time of consent
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01464645
Start Date
January 1 2012
End Date
December 1 2017
Last Update
October 10 2018
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopaedic Surgery Specialists
Burbank, California, United States, 91505
2
Stanford Medical Center Outpatient Clinic
Redwood City, California, United States, 94063
3
Syracuse Orthopaedic Specialists
Syracuse, New York, United States, 13214
4
McBride Clinic
Oklahoma City, Oklahoma, United States, 73103