Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
Primary Purpose
Osteoarthritis, Avascular Necrosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total hip replacement components
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Lexington Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Posterior approach
Anterior Approach
Arm Description
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.
Outcomes
Primary Outcome Measures
Time to discontinued use of an assistive ambulatory device (cane or walker)
Secondary Outcome Measures
modified Harris Hip Score
SF-12
Lower Extremity Functional Score
Functional force testing
Testing to objectively quantify subject function when rising from a chair and descending stairs
implant survivorship
Length of hospital stay
Operative time
Number of patients that require blood transfusion
Full Information
NCT ID
NCT01807494
First Posted
March 4, 2013
Last Updated
October 5, 2015
Sponsor
New Lexington Clinic
Collaborators
Biomet Orthopedics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01807494
Brief Title
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
Official Title
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Lexington Clinic
Collaborators
Biomet Orthopedics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior approach
Arm Type
Active Comparator
Arm Description
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
Arm Title
Anterior Approach
Arm Type
Active Comparator
Arm Description
Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.
Intervention Type
Device
Intervention Name(s)
Total hip replacement components
Other Intervention Name(s)
Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+
Intervention Description
All patients will receive the same implants
Primary Outcome Measure Information:
Title
Time to discontinued use of an assistive ambulatory device (cane or walker)
Time Frame
6 week postoperative follow-up
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Functional force testing
Description
Testing to objectively quantify subject function when rising from a chair and descending stairs
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
Title
implant survivorship
Time Frame
1-, 2-, 5-, 7-, and 10-year follow-ups
Title
Length of hospital stay
Time Frame
Collected during the hospital stay (usually 1 to 5 days)
Title
Operative time
Time Frame
Intra-operative
Title
Number of patients that require blood transfusion
Time Frame
Intra-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian P Christensen, MD
Organizational Affiliation
Lexington Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
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