- Department of Neuroscience, Winthrop Neuroscience, Winthrop University Hospital, Mineola, New York, USA
Nancy E. Epstein
Department of Neuroscience, Winthrop Neuroscience, Winthrop University Hospital, Mineola, New York, USA
DOI:10.4103/2152-7806.191061Copyright: © 2016 Surgical Neurology International This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
How to cite this article: Epstein NE. Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34. Surg Neurol Int 22-Sep-2016;7:
How to cite this URL: Epstein NE. Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34. Surg Neurol Int 22-Sep-2016;7:. Available from: http://surgicalneurologyint.com/surgicalint_articles/commentary-laminectomy-plus-fusion-versus-laminectomy-alone-lumbar-spondylolisthesis-ghogawala-z-dziura-j-butler-dai-f-terrin-n-magge-sn-et-al-nejm-2016374-151424%e2%80%9134/
Background:How does an article involving only 66 patients randomized into two spinal surgical groups get into the New England Journal of Medicine? Nevertheless, this one did. The article by Ghogawala et al. entitled Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis, compared the efficacy/outcomes of pedicle/screw/rod instrumented posterolateral lumbar fusions vs. decompressions alone for treating lumbar stenosis with grade I degenerative spondylolisthesis (DS).
Methods:They designed a randomized controlled study involving only 66 patients between the ages of 50–80 (average age: 67) with lumbar stenosis and stable DS (3–14 mm). Outcomes were measured utilizing the physical measures from the Short Form 36 (SF-36) up to 4 postoperative years, and the Oswestry Disability Index (ODI) upt to 2 postoperative years. Data were available for 86% of patients at 2, but only for 68% of the patients at 4 postoperative years.
Results:At 2 postoperative years, SF-36 scores were higher for the instrumented patients (28 patients) vs. decompressed (29 patients) patients. However, the scores were comparable for both groups using the ODI at 4 years. SF-36 scores, however, remained higher for the 19 remaining instrumented patients. Additionally, reoperation rates were 14% for fusions and a staggering 34% for decompressions alone.
Conclusions:The authors concluded; laminectomy with fusion offered a “slightly greater but clinically meaningful improvement in overall physical health-related quality of life vs. laminectomy alone.” Rather, it should have read there were no statistically significant differences between the two groups and an insufficient number of patients were included in the study at all stages.
Keywords: Efficacy study, fusion, laminectomy, lumbar spondylolisthesis
How does an article involving only 66 patients randomized into two spinal surgical groups get into the New England Journal of Medicine (NEJM)? Nevertheless, this one did. The article by Ghogawala et al. entitled Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis, compared the efficacy/outcomes of pedicle/screw/rod instrumented posterolateral lumbar fusions versus decompressions alone for treating lumbar stenosis with grade I degenerative spondylolisthesis (DS). The question was whether fusion would offer greater improvement/outcomes versus decompression alone.
MATERIALS AND METHODS
The authors designed a randomized controlled study that ended up involving just 66 patients between the ages of 50–80 (average age: 67) with lumbar stenosis and “stable” DS (3-14 mm). Originally, the authors wanted to enroll 100 patients and to randomly assign at least 64, along with maintaining 40 patients in an observational cohort. However, here, the original 66 patients declined by 2 years to 57 patients (86%) and by 4 years to only 45 (68%) patients. Of interest, the study was originally scheduled to run for 5 years, but the dropout rate was too high.
The surgical procedures offered to address stenosis/DS included decompression alone versus decompression with posterolateral lumbar instrumented pedicle screw/rod fusion. Decompressions reportedly included; “complete laminectomy with partial removal of the medial facet joint.” Those undergoing fusion had laminectomy with pedicle/screw/rod instrumentation and iliac crest autograft applied over the transverse processes.
Surgeon enrollment criteria
Notably, for surgeons to enroll their patients in the study, they had to have performed only 100 laminectomies and 100 laminectomies with posterolateral instrumented fusions. This meant that a number of the surgeons were neophytes, and/or just out of residency. Certainly, it might help explain the high reoperation rate for laminectomy alone wherein they likely inadvertently removed much more than the medial facet, thus resulting in a higher rate of postoperative instability.
Outcomes were measured utilizing the physical measures of the Short Form 36 (SF-36) and Oswestry Disability Index (ODI: Secondary measure) at 2 years postoperatively; 4 year outcomes were reported utilizing the SF-36. They also reported complications and the reoperation rates for each operative group. Notably, data were collected by study coordinators who also but “not explicitly” collected information on blood loss, operative time, and length of hospital stay (LOS).
The authors devoted most of the first paragraph of the results section to reviewing the number of patients not included in the study. Originally, 130 patients were identified; 66 (average age: 67) consented to become randomized (1 never underwent surgery), but 40 did not (agreed to be in the observational group).
At 2 postoperative years, SF-36 scores were higher for the instrumented patients (28 patients) versus decompressed (29 patients). Conclusions for the SF-36 outcomes at 2 postoperative years were based on the following analysis; 24 of 28 in the fusion group and 20 of 29 in the decompression groups had “a prespecified minimal clinically important difference of 5 points in the SF-36 physical component summary score.” It appears that with such small numbers and the complex statistical analysis performed that the authors were markedly “over-reaching” the given limitations of their data. They also observed that at 4 postoperative years, SF-36 scores still remained higher for instrumented patients (19 patients) vs. decompressed patients (26 patients); again, “over-reaching” would be my opinion, paritcularly considering the much reduced number of patients left in each cohort. Of interest, the ODI data failed to show any differences for the low back pain scores at 2, 3, and 4 postoperative years. Perhaps, this is why they considered the ODI their “secondary” outcome measure (e.g. in an attempt to ignore these findings).
The reoperation rate was 14% for those undergoing fusions, and predominantly addressed adjacent level disease.
Notably, a staggering, unprecedented 34% reoperation rate was observed for those undergoing decompressions alone (e.g. requiring reoperations predominantly at the index level). For this latter group, one has to again ask, were neophytes performing these decompressions and was the reoperation rate so high because they were sacrificing more than the medial facet on a regular basis?
Longer length of stay and blood loss for fusion procedures
As anticipated, longer lengths of stay (LOS) and greater estimated blood loss were noted for patients undergoing instrumented fusions.
Many would agree with Weinstein et al. who reported that patients with spinal stenosis/DS undergoing surgery have better outcomes at 2 postoperative years versus those not undergoing any surgery.[
Nevertheless, other multiple other studies have demonstrated comparable outcomes with/without fusion for treating spinal stenosis with DS.[
Increased risks of adjacent level disease with instrumented lumbar fusion
Many studies have cited the increased risk of adjacent level disease following instrumented lumbar fusions performed for degenerative lumbar disease/stenosis with/without DS. In this study, Ghogawala et al. cited a 14% reoperation rate following decompressive laminectomy with instrumented posterolateral pedicle/screw fusions to address new adjacent level disease.[
Limitations of this study
Ghogawala et al. tried very hard to avoid confronting the marked limitations of this study and its lack of statistical significance. They repeatedly stated that they originally screened 130 patients, enrolled 106, but unfortunately, only 66 remained to be randomly assigned to the treatment groups.[
Ghogawala et al. concluded that for patients with spinal stenosis and DS, laminectomy with fusion offered a “slightly greater but clinically meaningful improvement in overall physical health-related quality of life vs. laminectomy alone.” Rather, it should have read that there were no statistically significant differences between the two treatment groups, and that the number of patients in the study was insufficient at all stages. In short, I would again ask: How did this article involving only 66 patients randomized into two spinal surgical groups get into the NEJM?
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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