Swan Justin, Hurwitz Eric, Malek Farbod, van den Haak Erica, Cheng Ivan, Alamin Todd, Carragee Eugene
Department of Orthopaedic Surgery, Spine Surgery Section, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305-5326, USA.
Spine J. 2006 Nov-Dec;6(6):606-14. doi: 10.1016/j.spinee.2006.02.032. Epub 2006 Oct 2.
The surgical treatment for low-grade isthmic spondylolisthesis in adults with intractable lumbar pain is usually spinal fusion. It has been postulated that anterior column reconstruction may be relatively advantageous in those patients with unstable slips.
To compare the early and medium term treatment efficacy of two common fusion techniques in isthmic spondylolisthesis.
STUDY DESIGN/SETTING: Prospective controlled trial comparing single-level posterior-lateral instrumented fusion with combined anterior and posterior-lateral instrumented fusion in sequential matched cohorts of patients with radiographically unstable isthmic spondylolisthesis.
Primary outcome measure of success was an Oswestry Disability Index (ODI)<or=20. Secondary outcome measures included patient determined minimum-acceptable outcome on four questionnaires: pain intensity (visual analog scale), ODI, medication intake, and work status. Radiographic outcome of fusion was determined by radiographic union and motion on flexion/extension X-rays. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for primary outcome of success for combined fusion compared with posterior fusion.
The study was conducted over a 6-year period. The first cohort of 50 consecutive patients was treated with a single-level instrumented posterior-lateral fusion; the second sequential cohort was treated with an anterior interbody fusion and the same posterior operation. Observations were made at baseline, 6 months, 1 year, and 2 years after surgery. Final radiographic assessment was made at 2 years after surgery.
Baseline demographic and clinical factors were well-matched in the two cohorts. At 2 years, 46 posterior-only fusion subjects and 47 combined fusion subjects completed the full follow-up regimen. Outcomes were better by all measures at 6 months and 12 months in the anterior-posterior cohort. Comparing the primary outcome measure (ODI outcome<or=20) in the posterior versus the combined groups, success was achieved at 6 months in 11 versus 30 (RR=2.67, 95% CI 1.53, 4.67; p=.0001); at 1 year, 20 versus 34 (RR=1.66, 95% CI 1.14, 2.42; p<.005); and at 2 years, 29 versus 36 subjects (RR=1.21, 95% CI 0.93, 1.59; p=.14). At 6 months, 13 posterior-only and 25 combined group subjects had returned to work (RR 1.88, 95% CI 1.10, 3.21; p=.01). More patients achieved their preoperatively determined minimum-acceptable outcome at each time point. There were three nonunions in the posterior-alone cohort and one in the combined group. Serious complications and reoperations were similar in both groups.
Outcomes up to 2 years were superior by clinically important differences after a combined anterior-posterior operation compared with posterior-alone surgery for unstable spondylolisthesis; however, between-group differences attenuated appreciably after 6 months. The apparent clinical and occupational benefits of combined fusion should be considered along with possible increases in minor complications and procedure-related costs.
成人低位峡部裂型腰椎滑脱伴顽固性腰痛的手术治疗通常为脊柱融合术。据推测,对于伴有不稳定滑脱的患者,前柱重建可能具有相对优势。
比较两种常见融合技术治疗峡部裂型腰椎滑脱的早期和中期疗效。
研究设计/地点:前瞻性对照试验,在影像学不稳定的峡部裂型腰椎滑脱患者的连续匹配队列中,比较单节段后侧方器械辅助融合与前后侧方联合器械辅助融合。
成功的主要观察指标为Oswestry功能障碍指数(ODI)≤20。次要观察指标包括患者在四份问卷上自行确定的最小可接受结果:疼痛强度(视觉模拟评分)、ODI、药物摄入量和工作状态。融合的影像学结果通过影像学骨愈合及屈伸位X线片上的活动度来确定。计算联合融合与后侧融合成功的主要观察指标的风险比(RRs)及95%置信区间(CIs)。
本研究为期6年。第一组连续50例患者接受单节段器械辅助后侧方融合治疗;第二组连续患者接受前路椎间融合及相同的后路手术。在基线、术后6个月、1年和2年进行观察。术后2年进行最终影像学评估。
两组的基线人口统计学和临床因素匹配良好。2年时,46例单纯后侧融合患者和47例联合融合患者完成了完整的随访方案。在6个月和12个月时,前后联合组的各项指标结果均更好。比较后侧组与联合组的主要观察指标(ODI结果≤20),6个月时,成功例数分别为11例和30例(RR = 2.67,95% CI 1.53,4.67;p = 0.0001);1年时,分别为20例和34例(RR = 1.66,95% CI 1.14,2.42;p < 0.005);2年时,分别为29例和36例(RR = 1.21,95% CI 0.93,1.59;p = 0.14)。6个月时, 13例单纯后侧组和25例联合组患者恢复工作(RR 1.88,95% CI 1.10,3.21;p = 0.01)。在每个时间点,更多患者达到了术前确定的最小可接受结果。单纯后侧组有3例骨不连,联合组有1例。两组的严重并发症和再次手术情况相似。
对于不稳定腰椎滑脱,前后联合手术与单纯后路手术相比,2年内的临床重要差异结果更优;然而,6个月后组间差异明显减小。联合融合明显的临床和职业益处应与轻微并发症可能增加及与手术相关的费用一并考虑。