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Cost-Effectiveness of Total Disc Replacement Versus Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain: A Norwegian Multicenter RCT

Johnsen, Lars Gunnar MD*,†,‡; Hellum, Christian MD, PhD§; Storheim, Kjersti PhD§,¶; Nygaard, Øystein P. MD, PhD*,‡; Brox, Jens Ivar MD, PhD§; Rossvoll, Ivar MD, PhD*,†,‡; Rø, Magne MD*,‡; Andresen, Hege MN*,‡; Lydersen, Stian PhD; Grundnes, Oliver MD, PhD**; Pedersen, Marit Cand. Polit††; Leivseth, Gunnar MD, PhD*,‡‡; Olafsson, Gylfi MSc§§,¶¶; Borgström, Fredrik PhD§§,¶¶; Fritzell, Peter MD, PhD‖‖; The Norwegian Spine Study Group

doi: 10.1097/BRS.0000000000000065
Randomized Trial

Study Design. Randomized clinical trial with 2-year follow-up.

Objective. To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP).

Summary of Background Data. The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR.

Methods. Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio.

Results. The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18–0.50). The mean total cost per patient in the TDR group was €87,622 (58,351) compared with €74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: −4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from €39,748 using EQ-5D (TDR cost-effective) to €128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D.

Conclusion. In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of €74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR.

Level of Evidence: 2

This randomized clinical trial compares total disc replacement (TDR) with multidisciplinary rehabilitation (MDR) in selected patients experiencing chronic low back pain. Although expensive, TDR was cost-effective because it yielded better health outcomes. However, the result was sensitive to the choice of instrument used to measure quality of life.

*Neuroclinic, Center of Spinal Disorder and

Department of Orthopaedic Surgery, Clinic of Orthopaedics and Rheumatology, St. Olavs Hospital, Trondheim University Hospital, Norway

Department of Neuroscience, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway

§Orthopaedic Department, Clinic for Surgery and Neurology, Oslo University Hospital and University of Oslo, Oslo, Norway

FORMI, Clinic for Surgery and Neurology, Oslo University Hospital, Oslo, Norway

Regional Centre for Child and Youth Mental Health and Child Welfare–Central Norway, Norwegian University of Science and Technology, Trondheim, Norway

**Aleris Hospital, Oslo, Norway

††SINTEF Technology and Society, Trondheim, Norway

‡‡Department of Clinical Medicine, Neuromuscular Diseases and Research Group, University of Tromsø, Tromsø, Norway

§§Quantify Research, Stockholm, Sweden

¶¶Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden; and

‖‖Ryhov Hospital, Jönköping, Sweden.

Address correspondence and reprint requests to Lars Gunnar Johnsen, MD, Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Olav Kyrres gt 4, 7005 Trondheim, Norway; E-mail: lars.gunnar.johnsen@ntnu.no

Acknowledgment date: May 21, 2013. Revision date: August 16, 2013. Acceptance date: September 23, 2013.

The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.

Jönköping län grant funds and the South Eastern Norway Regional Health Authority and EXTRA funds from the Norwegian Foundation for Health and Rehabilitation, through the Norwegian Back Pain Association funds were received in support of this work.

Relevant financial activities outside the submitted work: consultancy, payment for lecture, grants.

© 2014 by Lippincott Williams & Wilkins