Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach

Study Overview
=================
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.

Official Title
-----------------
Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach

Conditions
-----------------
Osteoarthritis of the Hip

Intervention / Treatment
-----------------
* Procedure: Anterior Approach / Posterior Approach
* Procedure: Anterior versus Posterior Approach for total hip replacement


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior Approach Total Hip<br>Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach | Procedure: Anterior Approach / Posterior Approach<br>* compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach<br>|
| Active Comparator: Posterior Approach Total Hip<br>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. | Procedure: Anterior versus Posterior Approach for total hip replacement<br>* Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Approach, Posterior Approach