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| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary | Post Market Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modular Revision Hip System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score Evaluation | 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). | 2 year |
| Number of Participants With Radiologic Failure of Device | 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. | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Levine, M.D. | Orthopedic Associates of Pittsburgh, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Surgery Specialists | Burbank | California | 91505 | United States | ||
| Stanford Medical Center Outpatient Clinic |
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| ID | Term |
|---|---|
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Redwood City |
| California |
| 94063 |
| United States |
| Syracuse Orthopaedic Specialists | Syracuse | New York | 13214 | United States |
| McBride Clinic | Oklahoma City | Oklahoma | 73103 | United States |
| Orthopedic Associates of Pittsburgh, Inc. | Monroeville | Pennsylvania | 15146 | United States |
| Texas Institute for Hip and Knee Surgery | Austin | Texas | 78751 | United States |