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OpenTrials
Completed

NCT Number: NCT01807104

Total Hip Arthroplasty (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).

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Orthopedic Associates

Renton, Washington, 98055, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anterior Approach / Posterior Approach

Procedure

compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Anterior versus Posterior Approach for total hip replacement

Procedure

Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Primary outcomes

  1. Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Barrett, William, M.D.

Indiv

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2013
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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