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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2007

Open Access 01-12-2007 | Study protocol

Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial

Authors: Inge HF Reininga, Robert Wagenmakers, Inge van den Akker-Scheek, A Dennis Stant, Johan W Groothoff, Sjoerd K Bulstra, Wiebren Zijlstra, Martin Stevens

Published in: BMC Musculoskeletal Disorders | Issue 1/2007

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Abstract

Background

Moderate to severe osteoarthrosis is the most common indication for Total Hip Arthroplasty (THA). Minimally Invasive Total Hip Surgery (MIS) and computer-navigated surgery were introduced several years ago. However, the literature lacks well-designed studies that provide evidence of superiority of computer-navigated MIS over a conventional THA technique. Hence, the purpose of this study is to compare (cost)effectiveness of computer-navigated MIS with a conventional technique for THA. It is our hypothesis that computer-navigated MIS will lead to a quicker recovery during the early postoperative period (3 months), and to an outcome at least as good 6 months postoperatively. We also hypothesize that computer-navigated MIS leads to fewer perioperative complications and better prosthesis positioning. Furthermore, cost advantages of computer-navigated MIS over conventional THA technique are expected.

Methods/design

A cluster randomized controlled trial will be executed. Patients between the ages of 18 and 75 admitted for primary cementless unilateral THA will be included. Patients will be stratified using the Charnley classification. They will be randomly allocated to have computer-navigated MIS or conventional THA technique. Measurements take place preoperatively, perioperatively, and 6 weeks and 3 and 6 months postoperatively. Degree of limping (gait analysis), self-reported functional status and health-related quality of life (questionnaires) will be assessed preoperatively as well as postoperatively. Perioperative complications will be registered. Radiographic evaluation of prosthesis positioning will take place 6 weeks postoperatively. An evaluation of costs within and outside the healthcare sector will focus on differences in costs between computer-navigated MIS and conventional THA technique.

Discussion

Based on studies performed so far, few objective data quantifying the risks and benefits of computer-navigated MIS are available. Therefore, this study has been designed to compare (cost) effectiveness of computer-navigated MIS with a conventional technique for THA. The results of this trial will be presented as soon as they become available.
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Metadata
Title
Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial
Authors
Inge HF Reininga
Robert Wagenmakers
Inge van den Akker-Scheek
A Dennis Stant
Johan W Groothoff
Sjoerd K Bulstra
Wiebren Zijlstra
Martin Stevens
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2007
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-8-4

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