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

Not Applicable

Completed

• Conditions: Osteoarthritis of the Hip
• Interventions: Procedure: Anterior Approach / Posterior Approach; Procedure: Anterior versus Posterior Approach for total hip replacement

• Registration Number: NCT01807104
• Lead Sponsor: Barrett, William, M.D.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Results First Submitted: 2019-05-05
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Results First Posted: 2019-08-29
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Approach Total Hip	Anterior Approach / Posterior Approach	Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach
Posterior Approach Total Hip	Anterior versus Posterior Approach for total hip replacement	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.

Primary Outcome Measures

Name	Time	Method
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach	5 years	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.

Trial Locations

Locations (1)

Valley Orthopedic Associates; 🇺🇸 Renton, Washington, United States