Post-Market Study of the Modular Revision Hip System (MRHS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aseptic Loosening Osteolysis Traumatic Fracture Failed Total Hip Implant |
Device: Modular Revision Hip System |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS) |
- Harris Hip Score Evaluation [ Time Frame: 2 year ] [ Designated as safety issue: No ]The Harris Hip Score was developed to evaluate hip function in patients with traumatic disorders of the hip, but it is now commonly used to follow patients after surgery for a degenerative disorder of the hip (Harris et al., 1969). The score is broken down into 4 areas (pain, function, deformity and range of motion), with the best possible score being 100. 44 points are allotted for pain, 47 for mobility/function, 5 for range of motion and 4 for absence of deformity. Grading for the Harris Hip Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
- Number of Participants With Radiologic Failure of Device [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]Radiographic failure is defined as a complete radiolucent line > 2mm wide at the Prosthesis/Bone Interface or a >3 Degree Migration varus/valgus or >3 mm Subsidence of the component.
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Primary
Post Market Study
|
Device: Modular Revision Hip System
Hip System that is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.
Other Name: MRHS
|
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 the most experienced surgeon. Loss of bone stock, joint stability, infection, fracture, trochanteric non-union, and difficulty in implant or cement removal are all potential issues that a surgeon must consider for each presenting patient. These challenges require hip implant systems to provide an intraoperative flexibility that is not normally required for primary THA. The Lima Modular Revision Hip System uses modular stem and neck components to allow for surgical versatility when selecting leg length, offset and version. The purpose of this study is to examine the short term safety and efficacy of the Modular Revision Hip System (MHRS) using radiologic success and Harris Hip Scores as endpoints. The study will take place at multiple sites across the United States and will include only subjects who meet the indications for use criteria for the Modular Revision Hip system and who are candidates for revision hip replacement surgery. Target enrollment will be 200 subjects with up to 25 subjects at 15 sites across the United States.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Eligible subjects will be at least 18 years of age at the time of consent and meet the inclusion criteria for a total hip revision arthroplasty due to poor bone stock, or due to deficiencies of the femoral head, neck or portions of the proximal femur.
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 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
Contacts and Locations| Contact: Derek E Coulter, BS | 512-834-6284 | derek.coulter@djoglobal.com |
| United States, California | |
| Orthopaedic Surgery Specialists | Recruiting |
| Burbank, California, United States, 91505 | |
| Principal Investigator: Shahan V Yacoubian, M.D. | |
| Sub-Investigator: Stephan V. Yacoubian, M.D. | |
| United States, Florida | |
| Coastal Orthopedics & Sports Medicine | Recruiting |
| Bradenton, Florida, United States, 34209 | |
| Principal Investigator: John R. Ayres, M.D. | |
| Florida Orthopaedic Institute | Not yet recruiting |
| Tampa, Florida, United States, 33629 | |
| Principal Investigator: David T. Watson, M.D., FRCSC | |
| United States, Idaho | |
| St. Alphonsus Medical Group | Recruiting |
| Boise, Idaho, United States, 83706 | |
| Principal Investigator: Dennis R. McGee, M.D. | |
| United States, New Mexico | |
| New Mexico Orthopedics | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Sub-Investigator: Joshua T. Carothers, M.D. | |
| Principal Investigator: Krishna R. Tripuraneni, M.D. | |
| United States, New York | |
| NYU Hospital for Joint Diseases | Not yet recruiting |
| New York, New York, United States, 10003 | |
| Principal Investigator: Claudette LaJam, M.D. | |
| Syracuse Orthopaedic Specialists | Recruiting |
| Syracuse, New York, United States, 13214 | |
| Principal Investigator: Michael T. Clarke, M.D. | |
| United States, Ohio | |
| SportsMedicine Grant & Orthopaedic Association | Not yet recruiting |
| Columbus, Ohio, United States, 43215 | |
| Principal Investigator: Robert Fada, M.D. | |
| United States, Oklahoma | |
| McBride Clinic | Recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Principal Investigator: Thomas K Tkach, M.D. | |
| United States, Pennsylvania | |
| Orthopedic Associates of Pittsburgh, Inc. | Recruiting |
| Monroeville, Pennsylvania, United States, 15146 | |
| Principal Investigator: Michael Levine, M.D. | |
| United States, Texas | |
| Texas Institute for Hip and Knee Surgery | Recruiting |
| Austin, Texas, United States, 78751 | |
| Contact: Kaitlin Brangan | |
| Principal Investigator: David A. Dodgin, M.D. | |
| Sub-Investigator: Eric M. Heinrich, M.D. | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: Edward M. Nelsen-Freund, M.D. | |
| Principal Investigator: | Michael Levine, M.D. | Orthopedic Associates of Pittsburgh, Inc. |
More Information
No publications provided
| Responsible Party: | Encore Medical, L.P. |
| ClinicalTrials.gov Identifier: | NCT01464645 History of Changes |
| Other Study ID Numbers: | PS-804 |
| Study First Received: | November 2, 2011 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteolysis Bone Resorption Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013