Patients suffering from a lumbar herniated disc will typically present with signs and symptoms consistent with radiculopathy. They may also have low-back pain, however, and the source of this pain is less certain, as it may be from the degenerative process that led to the herniation. The surgical alternative of choice remains a lumbar discectomy, but fusions have been performed for both primary and recurrent disc herniations. In the original guidelines, the inclusion of a fusion for routine discectomies was not recommended. This recommendation continues to be supported by more recent evidence. Based on low-level evidence, the incorporation of a lumbar fusion may be considered an option when a herniation is associated with evidence of spinal instability, chronic low-back pain, and/or severe degenerative changes, or if the patient participates in heavy manual labor. For recurrent disc herniations, there is low-level evidence to support the inclusion of lumbar fusion for patients with evidence of instability or chronic low-back pain.
Jeffrey C. Wang, Andrew T. Dailey, Praveen V. Mummaneni, Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Michael W. Groff, Tanvir F. Choudhri, Jason C. Eck, Alok Sharan, Sanjay S. Dhall and Michael G. Kaiser
Daniel K. Resnick, William C. Watters III, Alok Sharan, Praveen V. Mummaneni, Andrew T. Dailey, Jeffrey C. Wang, Tanvir F. Choudhri, Jason Eck, Zoher Ghogawala, Michael W. Groff, Sanjay S. Dhall and Michael G. Kaiser
Patients presenting with stenosis associated with a spondylolisthesis will often describe signs and symptoms consistent with neurogenic claudication, radiculopathy, and/or low-back pain. The primary objective of surgery, when deemed appropriate, is to decompress the neural elements. As a result of the decompression, the inherent instability associated with the spondylolisthesis may progress and lead to further misalignment that results in pain or recurrence of neurological complaints. Under these circumstances, lumbar fusion is considered appropriate to stabilize the spine and prevent delayed deterioration. Since publication of the original guidelines there have been a significant number of studies published that continue to support the utility of lumbar fusion for patients presenting with stenosis and spondylolisthesis. Several recently published trials, including the Spine Patient Outcomes Research Trial, are among the largest prospective randomized investigations of this issue. Despite limitations of study design or execution, these trials have consistently demonstrated superior outcomes when patients undergo surgery, with the majority undergoing some type of lumbar fusion procedure. There is insufficient evidence, however, to recommend a standard approach to achieve a solid arthrodesis. When formulating the most appropriate surgical strategy, it is recommended that an individualized approach be adopted, one that takes into consideration the patient's unique anatomical constraints and desires, as well as surgeon's experience.
Zoher Ghogawala, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Tanya Logvinenko, Neil R. Malhotra, Stephen J. Dante, R. John Hurlbert, Andrea F. Douglas, Subu N. Magge, Praveen V. Mummaneni, Joseph S. Cheng, Justin S. Smith, Michael G. Kaiser, Khalid M. Abbed, Daniel M. Sciubba and Daniel K. Resnick
There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures.
An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform.
Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work.
It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).
Claire Blumenthal, Jill Curran, Edward C. Benzel, Rachel Potter, Subu N. Magge, J. Frederick Harrington Jr., Jean-Valery Coumans and Zoher Ghogawala
It is not known whether adding fusion to lumbar decompression is necessary for all patients undergoing surgery for degenerative lumbar spondylolisthesis with symptomatic stenosis. Determining specific radiographic traits that might predict delayed instability following decompression surgery might guide clinical decision making regarding the utility of up-front fusion in patients with degenerative Grade I spondylolisthesis.
Patients with Grade I degenerative lumbar spondylolisthesis (3–14 mm) with symptomatic stenosis were prospectively enrolled from a single site between May 2002 and September 2009 and treated with decompressive laminectomy without fusion. Patients with mechanical back pain or with gross motion (> 3 mm) on flexion-extension lumbar radiographs were excluded. The baseline radiographic variables measured included amount of slippage, disc height, facet angle, motion at spondylolisthesis (flexion-extension), and sagittal rotation angle. Data were analyzed using multivariate forward selection stepwise logistic regression, chi-square tests, Student t-test, and ANOVA.
Forty patients were enrolled and treated with laminectomy without fusion, and all patients had complete radiographic data sets that were available for analysis. Reoperation was performed in 15 (37.5%) of 40 patients, with a mean follow-up duration of 3.6 years. Reoperation was performed for pain caused by instability at the index level in all 15 cases. Using multivariate stepwise logistic regression with a threshold p value of 0.35, motion at spondylolisthesis, disc height, and facet angle were predictors of reoperation following surgery. Facet angle > 50° was associated with a 39% rate of reoperation, disc height > 6.5 mm was associated with a 45% rate of reoperation, and motion at spondylolisthesis > 1.25 mm was associated with a 54% rate of reoperation. Patients with all 3 risk factors for instability had a 75% rate of reoperation, whereas patients with no risk factors for instability had a 0% rate of reoperation (p = 0.14).
Patients with motion at spondylolisthesis > 1.25 mm, disc height > 6.5 mm, and facet angle > 50° are more likely to experience instability following decompression surgery for Grade I lumbar spondylolisthesis. Identification of key risk factors for instability might improve patient selection for decompression without fusion surgery. Clinical trial registration no.: NCT00109213
Zoher Ghogawala, Edward C. Benzel, Sepideh Amin-Hanjani, Fred G. Barker II, J. Fred Harrington, Subu N. Magge, John Strugar, Jean-Valéry C.E. Coumans and Lawrence F. Borges
Object. There is considerable debate among spine surgeons regarding whether fusion should be used to augment decompressive surgery in patients with symptomatic lumbar spinal stenosis involving Grade I degenerative spondylolisthesis. The authors prospectively evaluated the outcomes of patients treated between 2000 and 2002 at two institutions to determine whether fusion improves functional outcome 1 year after surgery.
Methods. Patients ranged in age from 50 to 81 years. They presented with degenerative Grade I (3- to 14-mm) spondylolisthesis and lumbar stenosis without gross instability (< 3 mm of motion at the level of subluxation). Those in whom previous surgery had been performed at the level of subluxation were excluded. Each patient completed Oswestry Disability Index (ODI) and Short Form—36 (SF-36) questionnaires preoperatively and at 6 to 12 months postoperatively.
Some patients underwent decompression alone (20 cases), whereas others underwent decompression and posterolateral instrumentation-assisted fusion (14 cases), at the treating surgeon's discretion. Baseline demographic data, radiographic features, and ODI and SF-36 scores were similar in both groups. The 1-year fusion rate was 93%.
Both forms of surgery independently improved outcome compared with baseline status, based on ODI and SF-36 physical component summary (PCS) results (p < 0.001). Decompression combined with fusion led to an improvement in ODI scores of 27.5 points, whereas decompression alone was associated with a 13.6-point increase (p = 0.02). Analysis of the SF-36 PCS data also demonstrated a significant intergroup difference (p = 0.003).
Conclusions. Surgery substantially improved 1-year outcomes based on established outcomes instruments in patients with Grade I spondylolisthesis and stenosis. Fusion was associated with greater functional improvement.