Avascular Necrosis, Osteoarthritis
Conditions
Brief summary
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.
Interventions
DEVICETotal hip replacement components
All patients will receive the same implants
Sponsors
Biomet Orthopedics, LLC
New Lexington Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Between ages of 18 and 85 * End stage hip joint degeneration * Has elected to undergo primary total hip arthroplasty
Exclusion criteria
* Undergoing revision arthroplasty * Inflammatory or rheumatoid arthritis * Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years) * Body Mass Index greater than 40 kg/m2 * Age \< 18 or \> than 85 * Previous ipsilateral hip surgery including arthroscopic procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to discontinued use of an assistive ambulatory device (cane or walker) | 6 week postoperative follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups | Testing to objectively quantify subject function when rising from a chair and descending stairs |
| 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 | — |
| 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 | — |
| implant survivorship | 1-, 2-, 5-, 7-, and 10-year follow-ups | — |
Countries
United States
Outcome results
None listed