Back to resultsTotal Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Primary Purpose
Osteoarthritis of the Hip
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior Approach / Posterior Approach
Anterior versus Posterior Approach for total hip replacement
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Hip focused on measuring Anterior Approach, Posterior Approach
Eligibility Criteria
Inclusion Criteria:
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
Exclusion Criteria:
- Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
- Subject has had previous surgery on the affected hip.
- Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
Sites / Locations
- Valley Orthopedic Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterior Approach Total Hip
Posterior Approach Total Hip
Arm Description
Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach
The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach.
Outcomes
Primary Outcome Measures
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
Secondary Outcome Measures
Full Information
NCT ID
NCT01807104
First Posted
June 16, 2011
Last Updated
July 25, 2019
Sponsor
Barrett, William, M.D.
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT01807104
Brief Title
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Official Title
Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barrett, William, M.D.
Collaborators
Johnson & Johnson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).
Detailed Description
The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.
The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip
Keywords
Anterior Approach, Posterior Approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior Approach Total Hip
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach
Arm Title
Posterior Approach Total Hip
Arm Type
Active Comparator
Arm Description
The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach.
Intervention Type
Procedure
Intervention Name(s)
Anterior Approach / Posterior Approach
Intervention Description
compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
Intervention Type
Procedure
Intervention Name(s)
Anterior versus Posterior Approach for total hip replacement
Intervention Description
Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
Primary Outcome Measure Information:
Title
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
Description
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is able to or capable of providing consent to participate in the clinical investigation.
Subject is between the ages of 20-75 years, inclusive.
Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
Subject has sufficient bone stock for the hip replacement device.
Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
Exclusion Criteria:
Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
Subject has had previous surgery on the affected hip.
Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William P Barrett, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Orthopedic Associates
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
12. IPD Sharing Statement
Links:
URL
https://doi.org/10.1016/j.arth.2019.01.060
Description
Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up Evaluation
Learn more about this trial
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
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