- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807494
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40504
- Lexington Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Posterior approach
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
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All patients will receive the same implants
Other Names:
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Active Comparator: Anterior Approach
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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All patients will receive the same implants
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to discontinued use of an assistive ambulatory device (cane or walker)
Time Frame: 6 week postoperative follow-up
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6 week postoperative follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified Harris Hip Score
Time Frame: 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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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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SF-12
Time Frame: 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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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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Lower Extremity Functional Score
Time Frame: 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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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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Functional force testing
Time Frame: 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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Testing to objectively quantify subject function when rising from a chair and descending stairs
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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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implant survivorship
Time Frame: 1-, 2-, 5-, 7-, and 10-year follow-ups
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1-, 2-, 5-, 7-, and 10-year follow-ups
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Length of hospital stay
Time Frame: Collected during the hospital stay (usually 1 to 5 days)
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Collected during the hospital stay (usually 1 to 5 days)
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Operative time
Time Frame: Intra-operative
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Intra-operative
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Number of patients that require blood transfusion
Time Frame: Intra-operative
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Intra-operative
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian P Christensen, MD, Lexington Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Cytochrome P-450 Enzyme Inhibitors
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Histamine H2 Antagonists
- Cimetidine
Other Study ID Numbers
- LCO.2012.05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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