Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis

Abstract

<jats:sec><jats:title>OBJECTIVE</jats:title><jats:p>A multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>Between July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity &lt; 35°, no neurological deficit, and an age of 16–60 years old. The present study represents a subset of those patients: 16 in the TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5–10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values derived using a multiple imputation procedure.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>The RMDQ score at 5–10 years postinjury was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the NO group (p = 0.486, 95% CI −2.3 to 4.8). Average kyphosis was 18.3° ± 2.2° for the TLSO group and 18.6° ± 3.8° for the NO group (p = 0.934, 95% CI −7.8 to 8.5). No differences were found between the NO and TLSO groups with time-weighted average treatment effects for RMDQ 1.9 (95% CI −1.5 to 5.2), for PCS −2.5 (95% CI −7.9 to 3.0), for MCS −1.2 (95% CI −6.7 to 4.2) and for average pain 0.9 (95% CI −0.5 to 2.2).</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>Compared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5–10 years.</jats:p></jats:sec>

Stabilometric Assesment of Postural Changes Induced by Spine Orthoses in a Geriatric Population

“…A multicenter, prospective, randomized comparison study between a thoracolombosacral orthosis (TLSO) and no orthoses (NO) in the treatment of acute A3 thoracolumbar fractures has shown that the two treatments that follow a similar management protocol are equivalent to 3 post-trauma months. After 5-10 years (mean follow-up 7.9 ± 1.1 years), patients treated without corset with early mobilization maintain the same pain relief (7). By studying the reaction to a sudden multiplanar dynamic stimulus, in orthostasis on the stabilometric platform it was possible to document which of the selected corsets had an action of greater control of the oscillations and therefore generally of control of the vertebral column (8).…”

Low value Injury Care in the Adult Orthopaedic Trauma Population: A Systematic Review

“…We identified three systematic reviews of RCTs (one with meta-analysis) 23,39,88 , six RCTs 27,55,65,73,80,81 , two retrospective cohort studies 30,32 and one economic evaluation 67 evaluating consultation with a spine surgeon for isolated thoracolumbar fracture and immobilization for thoracolumbar burst fracture, scaphoid fracture or fifth metacarpal neck fracture (Table 3). Prospective studies 30,32 identified no neurological deficit up to 6 months post-injury in patients who were not evaluated by a spine surgeon in the context of an isolated T1 to L5 transverse process fracture, mostly localized in the lumbar region.…”

The Role of Spinal Orthoses in Osteoporotic Vertebral Fractures of the Elderly Population (Age 60 Years or Older): Systematic Review

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