Fujiwara Hiroyasu, Makino Takahiro, Yonenobu Kazuo, Moriguchi Yu, Oda Takenori, Kaito Takashi
Department of Orthopaedic Surgery, National Hospital Organization, Osaka Minami Medical Center.
Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine.
Medicine (Baltimore). 2019 Apr;98(15):e15183. doi: 10.1097/MD.0000000000015183.
Lumbosacral orthoses (LSOs) are used as standard care after lumbar fusion surgery though their efficacy is unknown. The purpose of this prospective randomized controlled study was to elucidate the clinical and radiographic efficacies of LSO treatment in patients who underwent posterior lumbar interbody fusion (PLIF) of less than 3 segments.
Seventy-three patients who underwent PLIF were randomly allocated to 3 groups: 1 with custom-made LSO with metallic stays (C group); 1 with ready-made LSO without metallic stays (R group), and 1 without LSO (N group). The patients in the C and R groups were instructed to wear LSO postoperatively for 3 months. Clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) score, JOA-back pain evaluation questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire, and 100-mm visual analog scale for low back pain. Radiographic evaluation included intervertebral fusion rates and loss of correction postoperatively at 2 years.
A significant difference in the clinical outcomes was observed only for the lumbar dysfunction domain of JOABPEQ postoperatively at 1 month (N vs C groups; 45% vs 10%, P = .03). Radiographic outcomes were not different between the groups.
No effect of orthosis treatment for less than 3 segments in PLIF was observed on clinical and radiographic outcomes. The type of orthosis also did not influence the outcomes. These results suggest that the use of LSO for PLIF can be simplified or is omissible except in patients with severe osteoporosis.
腰骶矫形器（LSO）虽疗效未知，但在腰椎融合手术后作为标准护理手段使用。这项前瞻性随机对照研究的目的是阐明LSO治疗对接受少于3节段后路腰椎椎间融合术（PLIF）患者的临床和影像学疗效。
73例行PLIF手术的患者被随机分为3组：1组佩戴定制的带有金属支撑条的LSO（C组）；1组佩戴成品的无金属支撑条的LSO（R组）；1组不使用LSO（N组）。C组和R组患者术后被要求佩戴LSO 3个月。使用日本矫形外科学会（JOA）评分、JOA背痛评估问卷（JOABPEQ）、罗兰-莫里斯残疾问卷以及100毫米视觉模拟量表评估下腰痛，以此来评价临床疗效。影像学评估包括椎间融合率以及术后2年的矫正丢失情况。
仅在术后1个月时，JOABPEQ的腰椎功能障碍领域的临床疗效在N组和C组之间观察到显著差异（45%对10%，P = 0.03）。各组间影像学结果无差异。
未观察到PLIF中少于3节段的矫形器治疗对临床和影像学结果有影响。矫形器类型也未影响结果。这些结果表明，除严重骨质疏松患者外，PLIF使用LSO可简化或省略。
