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The MRC Spine Stabilization Trial: Surgical Methods, Outcomes, Costs, and Complications of Surgical Stabilization

Wilson-MacDonald, James FRCS, MCH*; Fairbank, Jeremy MA, FRCS, MD*; Frost, Helen†; Yu, Ly-Mee‡; Barker, Karen PhD, MCSP§; Collins, Rory¶; Campbell, Helen∥; the Spine Stabilization Trial Group

doi: 10.1097/BRS.0b013e318186a8b2
Health Services Research

Study Design. A review of the surgical costs and results in a group of patients randomly allocated to surgery as part of a large prospective randomized trial of patients with chronic back pain.

Objective. To report the observational data from the surgical arm of a randomized trial comparing surgery with intensive rehabilitation for chronic low back pain. Clinical and economic data are reported.

Summary of Background Data. Surgery for chronic low back pain is a well established but unproven intervention. The most cost-effective technique for spinal stabilization is still not established.

Methods. One hundred six patients with chronic low back pain were randomized to the surgical group of a randomized trial comparing spinal fusion of the lumbar with a 3 week intensive rehabilitation program. The primary outcomes were the Oswestry Disability Index (ODI) and the Shuttle Walking Test measured at baseline and 2 years postrandomization. Patients were stratified by preoperative diagnosis, smoking habit, and litigation. Complications were assessed and costs analyzed.

Results. Of the 176 surgical patients, 56 underwent postero-lateral fusion, 57 underwent interbody fusion, and 24 underwent flexible stabilization of the spine. The mean ODI for all patients in the surgical arm of the trial improved from a baseline of 46.5 (SD 14.6) to 34.2 (SD 21) at 2 years. Health care costs were higher (£3109 difference) for more complex procedures, and nearly 6 times as many early complications occurred with the more complex procedures. Smoking and unemployment were associated with worse results whereas litigation did not adversely affect the outcome.

Conclusion. These observational changes in the ODI after surgery are similar to those reported from otherstudies of spinal fusion. More complex surgery is more expensive with more complications than postero-lateral fusion.

A large cohort of patients undergoing spinal fusion surgery for low back pain was studied. Surgery had satisfactory outcomes at 2 years and more. No difference could be found in outcome between different surgical techniques. More complex surgery was more costly and resulted in higher complication and revision rates.

From the *Nuffield Orthopaedic Centre, Headington, Oxford, UK; †Division of Health in the Community, University of Warwick, Coventry, UK; ‡Centre for Statistics in Medicine, Wolfson College Annexe, Oxford, UK; §Department of Physiotherapy, Nuffield Orthopaedic Centre, Oxford, UK; ¶Clinical Trial Service Unit and Epidemiological Studies Unit, Radcliffe Infirmary, Oxford, UK; and ∥Department of Public Health, Health Economics Research Centre, University of Oxford, Oxford, UK.

Acknowledgment date: January 9, 2007. First revision date: November 1, 2007. Second revision date: February 6, 2008. Acceptance date: February 11, 2008.

Supported by a grant from the Medical Research Council of Great Britain.

The manuscript submitted does not contain information about medical device(s)/drug(s).

Foundation funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

Address correspondence and reprint requests to James Wilson-MacDonald, FRCS, MCH, Nuffield Orthopaedic Centre, Headington, Oxford, OX3 7LD, UK; E-mail: james.wilson-macdonald@noc.anglox.nhs.uk

© 2008 Lippincott Williams & Wilkins, Inc.