A Randomized Controlled Trial Comparing Transforaminal Lumbar Interbody Fusion and Uninstrumented Posterolateral Fusion in the Degenerative Lumbar Spine

摘要

Study Design Randomized controlled trial. Objective Despite a large number of publications of outcomes after spinal fusion surgery, there is still no consensus on the efficacy of the several different fusion methods. The aim of this study was to determine whether transforaminal lumbar interbody fusion (TLIF) results in an improved clinical outcome compared with uninstrumented posterolateral fusion (PLF) in the surgical treatment for chronic low back pain. Methods This study included 135 patients with degenerative disk disease ( n =?96) or postdiskectomy syndrome ( n =?39). Inclusion criteria were at least 1?year of back pain with or without leg pain in patients aged 20 to 65 with one- or two-level disease. Exclusion criteria were sequestration of disk hernia, psychosocial instability, isthmic spondylolisthesis, drug abuse, and previous spine surgery other than diskectomy. Pain was assessed by visual analog scale (pain index). Functional disability was quantified by the disability rating index and Oswestry Disability Index. The global outcome was assessed by the patient and classified as much better, better, unchanged, or worse. The patients were randomized to conventional uninstrumented PLF ( n =?67) or TLIF ( n =?68). PLF was performed in a standardized fashion using autograft. TLIF was performed with pedicle titanium screw fixation and a porous tantalum interbody spacer with interbody and posterolateral autograft. The clinical outcome measurements were obtained preoperatively and at 12 and 24 months postoperatively. The 2-year follow-up rate was 98%. Results The two treatment groups improved significantly from preoperatively to 2 years' follow-up. At final follow-up, the results in the TLIF group were significantly superior to those in the PLF group in pain index (2.0 versus 3.9, p =?0.007) and in disability rating index (22 versus 36, p =?0.003). The Oswestry Disability Index was better in the TLIF group (20 versus 28, p =?0.110, not significant). The global assessment was clearly superior in the TLIF group: 63% of patients scored “much better” in the TLIF group as compared with 48% in the PLF group ( p =?0.017). Conclusions The results of the current study support the use of TLIF rather than uninstrumented PLF in the surgical treatment of the degenerative lumbar spine. The less optimal outcome after uninstrumented PLF may be explained by the much higher reoperation rate. Keywords: chronic low back pain, transforaminal lumbar interbody fusion, posterolateral noninstrumented fusion