Posterolateral Surgical Approach Compared With Modified Lateral Approach

Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial

It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.

Study Overview

Detailed Description

Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.

We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gyeonggi-do
      • Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteonecrosis
  • primary or secondary osteoarthritis of the hips
  • femoral neck fracture.

Exclusion Criteria:

  • Patients with previous hemi- or total hip arthroplasty
  • highly dislocated or severe ankylosed hip
  • patients who are considered potentially unreliable or who may not reliably attend study visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: posterolateral approach
The posterolateral approach was described by many authors, but all share a common muscular interval in reference to the gluteus medius tendon. Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture.
Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture.
Other Names:
  • posterolateral approach
Active Comparator: modified lateral approach
The operative technique described modified lateral approach as described by Mulliken et al.
The operative technique described modified lateral approach as described by Mulliken et al.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
Time Frame: Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyung-Hoi Koo, Professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • SNU 03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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