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Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial.
BMC Musculoskelet Disord. 2007 Jan 11; 8:4.BM

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.

Authors+Show Affiliations

Department of Orthopedics, University Medical Center Groningen, University of Groningen, PO Box 30001, 9700 RB Groningen, The Netherlands. i.reininga@orth.umcg.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17214906

Citation

Reininga, Inge H F., et al. "Effectiveness of Computer-navigated Minimally Invasive Total Hip Surgery Compared to Conventional Total Hip Arthroplasty: Design of a Randomized Controlled Trial." BMC Musculoskeletal Disorders, vol. 8, 2007, p. 4.
Reininga IH, Wagenmakers R, van den Akker-Scheek I, et al. Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial. BMC Musculoskelet Disord. 2007;8:4.
Reininga, I. H., Wagenmakers, R., van den Akker-Scheek, I., Stant, A. D., Groothoff, J. W., Bulstra, S. K., Zijlstra, W., & Stevens, M. (2007). Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial. BMC Musculoskeletal Disorders, 8, 4.
Reininga IH, et al. Effectiveness of Computer-navigated Minimally Invasive Total Hip Surgery Compared to Conventional Total Hip Arthroplasty: Design of a Randomized Controlled Trial. BMC Musculoskelet Disord. 2007 Jan 11;8:4. PubMed PMID: 17214906.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial. AU - Reininga,Inge H F, AU - Wagenmakers,Robert, AU - van den Akker-Scheek,Inge, AU - Stant,A Dennis, AU - Groothoff,Johan W, AU - Bulstra,Sjoerd K, AU - Zijlstra,Wiebren, AU - Stevens,Martin, Y1 - 2007/01/11/ PY - 2006/11/16/received PY - 2007/01/11/accepted PY - 2007/1/12/pubmed PY - 2007/2/23/medline PY - 2007/1/12/entrez SP - 4 EP - 4 JF - BMC musculoskeletal disorders JO - BMC Musculoskelet Disord VL - 8 N2 - 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. SN - 1471-2474 UR - https://www.unboundmedicine.com/medline/citation/17214906/Effectiveness_of_computer_navigated_minimally_invasive_total_hip_surgery_compared_to_conventional_total_hip_arthroplasty:_design_of_a_randomized_controlled_trial_ L2 - https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-8-4 DB - PRIME DP - Unbound Medicine ER -