Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis.
OBJECTIVE 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. ⋯ 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). CONCLUSIONS 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.
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Randomized Controlled Trial Multicenter Study
Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial.
OBJECTIVE The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF). METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. ⋯ Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months. CONCLUSIONS The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion. Clinical trial registration no.: NCT00637156 (clinicaltrials.gov).
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OBJECTIVE Pedicle subtraction osteotomy (PSO) is commonly performed for correction of spinal sagittal plane deformities. The PSO results in complex, multiple changes of the spinopelvic alignment. The influence of the variability of individual pelvic morphology has not been fully analyzed in previous outcome studies of sagittal imbalance. ⋯ CONCLUSIONS PSO resulted in a substantial correction of sagittal imbalance and improved outcome in most patients in this study. Correction of the global sagittal balance appears to be a necessary precondition for a good outcome. A harmonious spine with a TK and an LL of similar magnitude seems to add to a positive outcome.
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Comparative Study
Pedicle subtraction osteotomy: a comprehensive analysis in 104 patients. Does the cause of deformity influence the outcome?
OBJECTIVE The clinical outcomes and complications of patients who underwent pedicle subtraction osteotomy (PSO) for various diagnoses were compared. More specifically, the purpose was to identify if outcomes differed between patients with flat-back syndrome after lumbar fusion (FBS-LF) versus patients who underwent surgery for adult spinal deformity (ASD). METHODS A retrospective analysis of 104 patients who underwent a PSO for sagittal plane imbalance was performed. ⋯ CONCLUSIONS PSO is a safe and effective method for correcting sagittal plane imbalance due to multiple etiologies. The authors found patient satisfaction to be high, and health-related quality of life was greatly improved by the procedure in patients with ASD. In contrast, in FBS-LF patients, a suboptimal outcome was observed and the cautious use of PSO seems warranted in this subset of patients.
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OBJECTIVE The ability to assess the risk of adverse events based on known patient factors and comorbidities would provide more effective preoperative risk stratification. Present risk assessment in spine surgery is limited. An adverse event prediction tool was developed to predict the risk of complications after spine surgery and tested on a prospective patient cohort. ⋯ The RAT was more accurate than the ACS NSQIP calculator (p = 0.0018). CONCLUSIONS While the RAT and ACS NSQIP calculator were both able to identify patients more likely to experience complications following spine surgery, both have substantial room for improvement. Risk stratification is feasible in spine surgery procedures; currently used measures have low accuracy.