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Comparison of Total Hip Arthroplasty Performed with and without Cement

A Randomized Trial

Investigation performed at the Institute for Clinical Evaluative Sciences, Toronto, Ontario; Division of Orthopedic Surgery, London Health Sciences Centre, University of Western Ontario, London, Ontario; Faculty of Pharmacy and Pharmaceutical Sciences,University of Alberta, Edmonton, Alberta; Department of Medicine and Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario; and Robarts Research Institute for Clinical Evaluative Sciences, London, Ontario, Canada

Andreas Laupacis, MD, MSc, FRCPC
Institute for Clinical Evaluative Sciences, G-106, 2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada. E-mail address: alaupacis{at}ices.on.ca

Robert Bourne, MD, FRCSC
Cecil Rorabeck, MD, FRCSC
Division of Orthopedic Surgery, London Health Sciences Centre, University of Western Ontario, 399 Windermere Road, London, ON N6A 5A5, Canada. E-mail address for R. Bourne: robert.bourne@lhsc.on.ca

David Feeny, PhD
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB T5J 3N4, Canada. E-mail address: dfeeny@pharmacy.ualberta.ca

Peter Tugwell, MD, MSc, FRCPC
Department of Medicine and Epidemiology and Community Medicine, University of Ottawa, Institute of Population Health, Ottawa, ON K1N 6N5, Canada. E-mail address: ptugwell@uottawa.ca

Cindy Wong, MSc
London Clinical Trials Research Group, Robarts Research Institute for Clinical Evaluative Sciences, P.O. Box 5015, 100 Perth Drive, London, ON, N6A 5K8, Canada

In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from the Medical Research Council of Canada (currently Canadian Institutes of Health Research). None of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Background: This study was designed to compare the fixation of a Mallory-Head total hip prosthesis with and without cement.

Methods: Two hundred and fifty patients with osteoarthritis of the hip were randomized to receive a Mallory-Head total hip prosthesis designed for insertion with cement or the same prosthesis designed for insertion without cement. Neither the patient nor the outcomes assessor was aware of the type of prosthesis. Outcomes were assessed with respect to mortality, revision arthroplasty, health-related quality of life (evaluated with the Harris hip score, Merle d'Aubigné and Postel hip score, McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the time trade-off technique), and the six-minute-walk test. Patients were seen at three, six, and twelve months and yearly thereafter.

Results: The prosthesis was inserted with cement in 124 patients and without cement in 126 patients. The mean age of the patients was sixty-four years, 48% were female, and the mean duration of follow-up was 6.3 years. There were thirteen revisions in the group that had fixation with cement and six in the group that had fixation without cement (p = 0.11), and more femoral components were revised in the group that had fixation with cement (twelve versus one; p = 0.002). All health-related quality-of-life measures improved postoperatively in both groups.

Conclusions: In this randomized trial, the group that had the cemented Mallory-Head hip prostheses required more revisions of the femoral component than did the group with the cementless Mallory-Head prostheses, which was perhaps related to the titanium-alloy femoral stem. Our findings are specific to the implants evaluated in this study.

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