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

Osteoarthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807104
• Other study ID #: 20091819
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: July 20, 2017

Study information

• Verified date: July 2019
• Source: Barrett, William, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

Procedure:
• Anterior Approach / Posterior Approach
compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
• Anterior versus Posterior Approach for total hip replacement
Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Locations

Country	Name	City	State
United States	Valley Orthopedic Associates	Renton	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Barrett, William, M.D.	Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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