Comparison of thoracolumbosacral orthosis and no orthosis for the treatment of thoracolumbar burst fractures: interim analysis of a multicenter randomized clinical equivalence trial

Clinical article

Christopher S. Bailey M.D., M.Sc.(Surg), F.R.C.S.C.1, Marcel F. Dvorak M.D., F.R.C.S.C.2, Kenneth C. Thomas M.D., M.H.Sc., F.R.C.S.C.3, Michael C. Boyd M.D., F.R.C.S.C.2, Scott Paquett M.D., F.R.C.S.C.2, Brian K. Kwon M.D., Ph.D., F.R.C.S.C.2, John France M.D., F.R.C.S.C.4, Kevin R. Gurr M.D., F.R.C.S.C.1, Stewart I. Bailey M.D., F.R.C.S.C.1, and Charles G. Fisher M.D., M.H.Sc., F.R.C.S.C.2
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  • 1 London Health Science Centre, University of Western Ontario, London, Ontario;
  • | 2 Vancouver Hospital and Health Sciences, University of British Columbia, Vancouver, British Columbia;
  • | 3 Department of Surgery (Orthopedics) and Neurosciences, University of Calgary, Alberta, Canada; and
  • | 4 Orthopedics Department, University of West Virginia, Morgantown, West Virginia
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Object

The authors compared the outcome of patients with thoracolumbar burst fractures treated with and without a thoracolumbosacral orthosis (TLSO).

Methods

As of June 2002, all consecutive patients satisfying the following inclusion criteria were considered eligible for this study: 1) the presence of an AO Classification Type A3 burst fractures between T-11 and L-3, 2) skeletal maturity and age < 60 years, 3) admission within 72 hours of injury, 4) initial kyphotic deformity < 35°, and 5) no neurological deficit. The study was designed as a multicenter prospective randomized clinical equivalence trial. The primary outcome measure was the score based on the Roland-Morris Disability Questionnaire assessed at 3 months postinjury. Secondary outcomes are assessed until 2 years of follow-up have been reached, and these domains included pain, functional outcome and generic health-related quality of life, sagittal alignment, length of hospital stay, and complications. Patients in whom no orthotic was used were encouraged to ambulate immediately following randomization, maintaining “neutral spinal alignment” for 8 weeks. The patients in the TLSO group began being weaned from the brace at 8 weeks over a 2-week period.

Results

Sixty-nine patients were followed to the primary outcome time point, and 47 were followed for up to 1 year. No significant difference was found between treatment groups for any outcome measure at any stage in the follow-up period. There were 4 failures requiring surgical intervention, 3 in the TLSO group and 1 in the non-TLSO group.

Conclusions

This interim analysis found equivalence between treatment with a TLSO and no orthosis for thoracolumbar AO Type A3 burst fractures. The influence of a brace on early pain control and function and on long-term 1- and 2-year outcomes remains to be determined. However, the authors contend that a thoracolumbar burst fracture, in exclusion of an associated posterior ligamentous complex injury, is inherently a very stable injury and may not require a brace.

Abbreviations used in this paper:

AP = anteroposterior; RMDQ = Roland-Morris Disability Questionnaire; TLSO = thoracolumbosacral orthosis; SF-36 = 36-Item Short Form Health Survey; VAS = visual analog scale; VB = vertebral body; WCB = Workers' Compensation Board.

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