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| Name | Class |
|---|---|
| Biomet Orthopedics, LLC | INDUSTRY |
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Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.
In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.
A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior approach | Active Comparator | Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components. |
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| Anterior Approach | Active Comparator | Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip replacement components | Device | All patients will receive the same implants |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinued use of an assistive ambulatory device (cane or walker) | 6 week postoperative follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| modified Harris Hip Score | Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups | |
| SF-12 | Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian P Christensen, MD | Lexington Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexington Clinic | Lexington | Kentucky | 40504 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Lower Extremity Functional Score | Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups |
| Functional force testing | Testing to objectively quantify subject function when rising from a chair and descending stairs | Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups |
| implant survivorship | 1-, 2-, 5-, 7-, and 10-year follow-ups |
| Length of hospital stay | Collected during the hospital stay (usually 1 to 5 days) |
| Operative time | Intra-operative |
| Number of patients that require blood transfusion | Intra-operative |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |