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

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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Hip
• Intervention / Treatment: Procedure: Anterior Approach / Posterior Approach; Procedure: Anterior versus Posterior Approach for total hip replacement

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98055
      • Valley Orthopedic Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is able to or capable of providing consent to participate in the clinical investigation.
2. Subject is between the ages of 20-75 years, inclusive.
3. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
4. Subject has sufficient bone stock for the hip replacement device.
5. 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:

1. Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
2. Subject has had previous surgery on the affected hip.
3. Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anterior Approach Total Hip; 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; compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
Active Comparator: Posterior Approach Total Hip; 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; Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

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

Collaborators and Investigators

• Sponsor: Barrett, William, M.D.
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: William P Barrett, MD

Publications and helpful links

Helpful Links

• Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up Evaluation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Anterior Approach; Posterior Approach
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 20091819