Posterolateral Surgical Approach Compared With Modified Lateral Approach

NCT ID: NCT00936949

Last Updated: 2013-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

surgical approach

Intervention Type PROCEDURE

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.

modified lateral approach

The operative technique described modified lateral approach as described by Mulliken et al.

Group Type ACTIVE_COMPARATOR

modified lateral approach

Intervention Type PROCEDURE

The operative technique described modified lateral approach as described by Mulliken et al.

Interventions

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surgical approach

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.

Intervention Type PROCEDURE

modified lateral approach

The operative technique described modified lateral approach as described by Mulliken et al.

Intervention Type PROCEDURE

Other Intervention Names

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posterolateral approach

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul national University Bundang Hospital

Principal Investigators

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Kyung-Hoi Koo, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNU 03-01

Identifier Type: -

Identifier Source: org_study_id

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