Noninstrumented Fusion Research Articles

High lumbar noninstrumented fusion rates using lamina autograft and Nanoss/bone marrow aspirate.

Background:Patients with marked osteoporosis and/or obesity/morbid obesity and severe multilevel lumbar stenosis and other pathology often undergo multilevel laminectomies with non instrumented posterolateral fusions (PLF). The other pathology may include combinations of degenerative spondylolisthesis/lysis, foraminal/far lateral discs, and/or synovial cysts requiring more extensive facet resections. Presently, spine surgeons often use bone graft expanders to supplement the lamina autograft harvested in the course of laminectomy/decompressions for the PLF mass.Methods:In 59 patients, we prospectively analyzed the fusion rates following multilevel laminectomies/noninstrumented fusions using lamina autograft and the bone graft expander Nanoss (RTI Surgical Alachua, FL, and USA) with autogenous bone marrow aspirate (BMA). Patients averaged 66.1 years of age; many exhibited marked osteoporosis (48 patients) and obesity (13 of 27 morbidly obese). Magnetic resonance (MR) and computed tomography (CT) studies documented stenosis/ossified yellow ligament (OYL) and degenerative spondylolisthesis (51 patients)/lysis (2 patients), synovial cysts (32 patients), and disc herniations (10 of 21 far lateral). Patients were followed remove up for an average of 3.12 years.Results:Average 4.0 level laminectomies/1.2 level noninstrumented fusions utilized lamina autograft and Nanoss/BMA. Both X-ray/CT studies performed an average of 4.9 months postoperatively documented a 97% fusion rate (57 of 59 patients). Two patients with severe osteoporosis, morbid obesity, and smoking histories exhibited pseudarthroses; neither was sufficiently symptomatic to require secondary surgery.Conclusions:Fifty-nine patients with multilevel lumbar stenosis/OYL and other pathology underwent multilevel lumbar laminectomies/noninstrumented fusions using lamina autograft and Nanoss/BMA. Both dynamic X-ray/CT studies confirmed a 97% fusion rate an average of 4.9 months postoperatively. Nanoss/BMA contributed to a high posterolateral lumbar non instrumented fusion rate without complciations.

RADIOLOGICAL ASSESSMENT OF BONY UNION AFTER OCCIPITOCERVICAL FUSION

Study design: Assessment of posterior occipitocervical fusions, based on the post-operative (postop) follow-up radiographic findings. Objectives: To investigate an objective radiological evaluation method of the occipitocervical stabilization and fusion. Summary of Background data: For evaluation of the union of the non-instrumented or instrumented stabilization and bony fusion of the occipitocervical segments, only a few studies have been performed by some previous authors. Material and Methods: Occipitocervical fusions were performed in 20 patients from 1995 to 2007. The patients underwent occipitocervical fusions with 4 different surgical methods; autogenous iliac bone grafts and wire fixation (seven cases), loop and sublaminar wire fixation (five cases), Cotrel–Dubousse (CD) occipitocervical rod (two cases), and contoured reconstruction plate and screw systems (six cases). The stability and established union of the fused segment and the instrument failure or loosening were evaluated with flexion/extension lateral radiograms. The stability was evaluated by alignment change in degrees and distances between a point of the occiput and cervical vertebrae on the sagittal plane radiograms, taken at postop three months ago. Angular motion over 2[Formula: see text] and 2[Formula: see text]mm of displacement on radiograms were defined to be unstable and/or ununited. When there was no such motion of the fused segment and the instrument breakage or loosening, the fused segment was judged stable and fused. Results: Diagnosis of nonunion was made in three out of seven patients who have undergone fusion with autogenous bone grafts with wire fixation. In the other patients, we were unable to determine the presence of a solid fusion mass at the fusion site, because of overlapping of the instrument and graft bones. In all rigidly instrumented cases, stability was obtained. Conclusion: The occipitocervical fusion segments were judged clinically to be stabilized rather than fused, if the flexion/extension radiographs, taken at postop three and six months, did not demonstrate motion at the fusion site.

Risk Factors for Reoperation in Patients Treated Surgically for Lumbar Stenosis: A Subanalysis of the 8-year Data From the SPORT Trial.

A retrospective subgroup analysis was performed on surgically treated patients from the lumbar spinal stenosis (SpS) arm of the Spine Patient Outcomes Research Trial (SPORT), randomized, and observational cohorts. To identify risk factors for reoperation in patients treated surgically for SpS and compare outcomes between patients who underwent reoperation with those who did not. SpS is one of the most common indications for surgery in the elderly; however, few long-term studies have identified risk factors for reoperation. A post-hoc subgroup analysis was performed on patients from the SpS arm of the SPORT, randomized and observational cohorts. Baseline characteristics were analyzed between reoperation and no-reoperation groups using univariate and multivariate analysis on data 8 years postoperation. Of the 417 study patients, 88% underwent decompression only, 5% noninstrumented fusion, and 6% instrumented fusion. At the 8-year follow-up, the reoperation rate was 18%; 52% of reoperations were for recurrent stenosis or progressive spondylolisthesis, 25% for complication or other reason, and 16% for new condition. Of patients who underwent a reoperation, 42% did so within 2 years, 70% within 4 years, and 84% within 6 years. Patients who underwent reoperation were less likely to have presented with any neurological deficit (43% reop vs. 57% no reop, P = 0.04). Patients improved less at follow-up in the reoperation group (P < 0.001). In patients undergoing surgical treatment for SpS, the reoperation rate at 8-year follow-up was 18%. Patients with a reoperation were less likely to have a baseline neurological deficit. Patients who did not undergo reoperation had better patient reported outcomes at 8-year follow-up compared with those who had repeat surgery. 2.

Is There a Role for Decompression Alone for Treating Symptomatic Degenerative Lumbar Spondylolisthesis?: A Systematic Review.

A posterior decompression with an instrumented fusion is one of the most common surgical procedures performed for treating symptomatic spinal stenosis associated with degenerative spondylolisthesis (DS). However, some patients may benefit from a decompression alone, avoiding complications related to instrumentation and fusion. To identify the characteristics of patients with symptomatic DS who may be successfully treated with an isolated decompression. A systematic literature review of studies including patients who underwent decompression without instrumentation for treatment of DS. A systematic review of the Medline database was performed. Retrospective and prospective studies of patients with DS who underwent a decompression were included, as well as studies comparing decompression with instrumented decompression. All the articles were classified according to their level of evidence. Thirteen studies met all inclusion and exclusion criteria. We identified several characteristics that may be associated with a less favorable outcome after a decompression alone: a facet angle >50 degrees, a disk space of >6.5 mm, presence of low back pain rather than lower extremity symptoms, presence of hypermobility in the listhetic level on dynamic radiographs (>1.25 to 2 mm), and resection of the posterior elements. The majority of the studies comparing decompression alone to decompression and instrumented fusion included in our review suggested similar clinical outcomes with both procedures; however, with long-term follow-up, fusion may provide better outcomes. Decompression with a noninstrumented fusion is also a good alternative to improve symptoms in selected patients, potentially decreasing the risk of reoperation compared with an instrumented fusion. Satisfactory clinical outcome can be achieved with an isolated decompression in selected patients, avoiding the additional risks and costs of instrumentation and spinal fusion. Noninstrumented fusion is also an interesting alternative to instrumented fusion for well-selected patients to decrease complications related to instrumentation.

Low reoperation rate following 336 multilevel lumbar laminectomies with noninstrumented fusions.

Background:Few reoperations are required in older patients undergoing multilevel lumbar laminectomy with noninstrumented fusions for spinal stenosis with/without spondylolisthesis/instability, and they rarely require instrumentation.Methods:We reviewed 336 patients averaging 66.5 years of age undergoing initial average 4.7 level lumbar laminectomies with average 1.4 level noninstrumented fusions over an average 7.1-year period (range 2.0–16.5 years). Patients uniformly exhibited spinal stenosis, instability (Grade I [195 patients] or Grade II spondylolisthesis [67 patients]), disc herniations (154 patients), and/or synovial cysts (66 patients). Reoperations, including for adjacent segment disease (ASD), addressed new/recurrent pathology.Results:Nine (2.7%) of 336 patients required reoperations, including for ASD, an average of 6.3 years (range 2–15 years) following initial 4.7 level laminectomies with 1.4 level noninstrumented fusions. Second operations warranted average 4.8 level (range 3–6) laminectomies and average 1.1 level non instrumented fusions addressing stenosis with instability (Grade I [7 patients] or Grade II [1 patient] spondylolisthesis), new disc herniations (2 patients), and/or a synovial cyst (1 patient).Conclusions:Only 9 (2.7%) of 336 patients required reoperations (including for ASD) consisting of multilevel laminectomies with noninstrumented fusions for recurrent/new stenosis even with instability; these older patients were not typically unstable, or were likely already fused, and did not require instrumentation. Alternatively, reoperation rates following instrumented fusions in other series approached 80% at 5 postoperative years. Therefore, we as spinal surgeons should realize that older patients even with instability rarely require instrumentation and that the practice of performing instrumented fusions in everyone, irrespective of age, needs to stop.

Older literature review of increased risk of adjacent segment degeneration with instrumented lumbar fusions.

Background:Adjacent segment degeneration (ASD) following lumbar spine surgery occurs in up to 30% of cases, and descriptions of such changes are not new. Here, we review some of the older literature concerning the rate of ASD, typically more severe cephalad than caudad, and highly correlated with instrumented fusions. Therefore, for degenerative lumbar disease without frank instability, ASD would be markedly reduced by avoiding instrumented fusions.Methods:In a prior review, the newer literature regarding the frequency of ASD following lumbar instrumented fusions (e.g., transforaminal or posterior lumbar interbody fusions [TLIF/PLIF] fusions or occasionally, posterolateral fusions [PLFs]) was presented. Some studies cited an up to an 18.5% incidence of ASD following instrumented versus noninstrumented fusions/decompressions alone (5.6%). A review of the older literature similarly documents a higher rate of ASD following instrumented fusions performed for degenerative lumbar disease alone.Results:More frequent and more severe ASD follows instrumented lumbar fusions performed for degenerative lumbar disease without instability. Alternatively, this entity should be treated with decompressions alone or with noninstrumented fusions, without the addition of instrumentation.Conclusions:Too many studies assume that TLIF, PLIF, and even PLF instrumented fusions are the “gold standard of care” for dealing with degenerative disease of the lumbar spine without documented instability. It is time to correct that assumption, and reassess the older literature along with the new to confirm that decompression alone and noninstrumented fusion avoid significant morbidity and even potentially mortality attributed to unnecessary instrumentation.

Results of Single-Staged Posterior Decompression and Circumferential Fusion Using a Transpedicular Approach to Correct a Kyphotic Deformity due to Thoracolumbar Spinal Tuberculosis.

Study DesignThis is a prospective study.PurposeThe aim of this study was to investigate the results of single-staged posterior decompression and circumferential fusion using a transpedicular approach to correct a kyphotic deformity due to thoracolumbar spinal tuberculosis.Overview of LiteratureSurgical management is frequently an imperative choice to achieve spinal decompression and deformity correction due to tuberculosis to relieve pain, improve neurology, and reconstruct the spine stability. Since the time anterior radical debridement and noninstrumented fusion was described, it has become apparent that even anterior debridement and bone grafting was often unsatisfactory in correcting or preventing the progression of kyphosis deformity. With the advent of modern segmental spinal instrumentation systems, isolated posterior instrumentation; combined anterior and posterior fusion; and single-staged posterior decompression and circumferential fusion have been described by many authors for correcting angular deformity and stabilizing the spine; however, there is a lack of consensus regarding the most effective means of correcting the deformity due to thoracolumbar spinal tuberculosis.MethodsThis is a prospective study of 20 patients with thoracolumbar spinal tuberculosis who underwent surgery at our institute.ResultsTwenty patients who were started on antituberculosis treatment underwent surgery using a single-staged posterior approach involving fixation, decompression, and kyphosis correction. Preoperatively, all patients had varying degrees of neurological deficit and a 27.45° average kyphotic angle, which improved. At the 1-year follow-up, correction was maintained at 6.9°, and 55% of patients showed neurological improvement. None of the patients experienced neurological deterioration. Two patients with lumbar spine tuberculosis underwent revision surgery because of nonunion.ConclusionsThe procedure of posterior decompression, fixation, and circumferential fusion using a transpedicular approach performed for thoracolumbar spinal tuberculosis is effective, safe, and excellent in correcting and maintaining kyphosis.

A review: Reduced reoperation rate for multilevel lumbar laminectomies with noninstrumented versus instrumented fusions.

Background:The reoperation rate, including for adjacent segment disease (ASD), is lower following multilevel lumbar laminectomy with noninstrumented versus instrumented fusions.Methods:This study reviews selected literature focusing on the reoperation rate, including for ASD, following multilevel laminectomies with noninstrumented versus instrumented fusions. Several prior studies document a 1.3–5.6% reoperation rate following multilevel laminectomy with/without noninstrumented fusions.Results:The reoperation rates for instrumented fusions, including for ASD, are substantially higher. One study cited a 12.2–18.5% frequency for reoperation following instrumented transforaminal lumbar and posterior lumbar interbody fusions (TLIF and PLIFs) at an average of 164 postoperative months. Another study cited a 9.9% reoperation rate for ASD 1 year following PLIF; this increased to 80% at 5 postoperative years. A further study compared 380 patients variously undergoing laminectomies/noninstrumented posterolateral fusions, laminectomies with instrumented fusions (PLFs), and laminectomies with instrumented PLF plus an interbody fusions; this study documented no significant differences in outcomes for any of these operations at 4 postoperative years. Furthermore, other series showed fusion rates for 1–2 level procedures which were often similar with or without instrumentation, while instrumentation increased reoperation rates and morbidity.Conclusions:Many studies document no benefit for adding instrumentation to laminectomies performed for degenerative disease, including spondylolisthesis. Reoperation rates for laminectomy alone/laminectomy with noninstrumented fusions vary from 1.3% to 5.6% whereas reoperation rates for ASD after instrumented PLIF was 80% at 5 postoperative years. This review should prompt spinal surgeons to reexamine when, why, and whether instrumentation is really necessary, particularly for treating degenerative lumbar disease.

Do in vivo kinematic studies provide insight into adjacent segment degeneration? A qualitative systematic literature review.

While much evidence suggests that adjacent segment degeneration is merely a manifestation of the natural degenerative process unrelated to any spine fusion, a significant body of literature supports the notion that it is a process due in part to the altered biomechanics adjacent to fused spine segments. The purpose of this study was to review and critically analyze the published literature that investigated the in vivo kinematics of the adjacent segments and entire lumbar spine in patients receiving spinal fusion or motion-preserving devices. A systematic review of the PubMed database was conducted, initially identifying 697 studies of which 39 addressed the in vivo kinematics of the segments adjacent to spinal implants or non-instrumented fusion of the lumbar spine. Twenty-nine articles studied fusion, of which three reported a decrease in range of motion of the caudal adjacent segment post-fusion. Examining the rostral adjacent segment, twelve studies observed no change, nine studies found a significant increase, and three studies reported a significant decrease in sagittal plane range of motion. Of the six studies that analyzed motion for the entire lumbar spine as a unit, five studies showed a significant decrease and one study reported no change in global lumbar spine motion. Kinematics of the segment rostral to a total disc replacement was investigated in six studies: four found no change and the results for the other two showed dependence on treatment level. Fifteen studies of non-fusion posterior implants analyzed the motion of the adjacent segment with two studies noting an increase in motion at the rostral level. There appears to be no overall kinematic changes at the rostral or caudal levels adjacent to a fusion, but some patients (~20-30%) develop excessive kinematic changes (i.e., instability) at the rostral adjacent level. The overall lumbar ROM after fusion appears to decrease after a spinal fusion.

Preliminary study showing safety/efficacy of nanoss bioactive versus vitoss as bone graft expanders for lumbar noninstrumented fusions.

Background:The lateral fusion mass for multilevel lumbar laminectomies with noninstrumented posterolateral fusions now often utilizes lamina autograft and bone marrow aspirate (BMA) mixed with one of two bone graft expanders: either Vitoss (Orthovita, Malvern, PA, USA) or NanOss Bioactive (Regeneration Technologies Corporation: RTI, Alachua, FL, USA).Methods:Here, we compared two sequential prospective the times to fusion, fusion rates, complications, and infection rates for two prospective cohorts of patients utilizing either Vitoss (first 213 patients) or NanOss (subsequent 45 patients) respectively, undergoing multilevel lumbar laminectomies (average 4.6 vs. 4.5 levels) with noninstrumented fusions (average 1.3 vs. 1.2 levels). Surgery addressed stenosis/ossification of the yellow ligament (OYL) (all patients), with subsets exhibiting degenerative spondylolisthesis synovial cysts, and disc disease. Fusion was documented by two independent neuroradiologists blinded to the study design, utilizing dynamic X-rays and two dimensional computed tomography (2D-CT) studies up to 6 months postoperatively, and up to 1 year where indicated.Results:Comparison of patients receiving Vitoss versus NanOss as bone graft expanders revealed nearly comparable; times to fusion (5.3 months vs. 4.8 months), fusion rates (210 [98.6%] vs. 45 [100%] patients), pseudarthroses (3 [1.4%] vs. 0), postoperative seromas (2 [0.94%] vs. 0), and deep wound infections (2 [0.94%] vs. 0).Conclusion:In this preliminary study of patients undergoing multilevel lumbar lamienctomies with posterolateral noninstrumented fusions, results were nearly comparable utilizing Vitoss or NanOss as bone graft expanders. Although the number of NanOss patients was substantially lower, the comparable efficacy and absence of postoperative complications for noninstrumented fusions is promising.

Tisseel does not reduce postoperative drainage, length of stay, and transfusion requirements for lumbar laminectomy with noninstrumented fusion versus laminectomy alone.

Background:Typically, fibrin sealants (FSs) and fibrin glues (FGs) are used to strengthen dural repairs during spinal surgery. In 2014, Epstein demonstrated that one FS/FG, Tisseel (Baxter International Inc., Westlake Village, CA, USA) equalized the average times to drain removal and length of stay (LOS) for patients with versus without excess bleeding (e.g. who did not receive Tisseel) undergoing multilevel laminectomies with 1-2 level noninstrumented fusions (LamF).[6]Methods:Here Tisseel was utilized to promote hemostasis for two populations; 39 patients undergoing average 4.4 level lumbar laminectomies with average 1.3 level noninstrumented fusions (LamF), and 48 patients undergoing average 4.0 level laminectomies alone (Lam). We compared the average operative time, estimated blood loss (EBL), postoperative drainage, LOS, and transfusion requirements for the LamF versus Lam groups.Results:The average operative times, EBL, postoperative drainage, LOS, and transfusion requirements were all greater for LamF versus Lam patients; operative times (4.1 vs. 3.0 h), average EBL (192.3 vs. 147.9 cc), drainage (e.g. day 1; 199.6 vs. 167.4 cc; day 2; 172.9 vs. 63.9 cc), average LOS (4.6 vs. 2.5 days), and transfusion requirements (11 LamF patients; 18 Units [U] RBC versus 2 Lam patients; 3 U RBC).Conclusions:Utilizing Tisseel to facilitate hemostasis in LamF versus Lam still resulted in greater operative times, EBL, postoperative average drainage, LOS, and transfusion requirements for patients undergoing the noninstrumented fusions. Although Tisseel decreases back bleeding within the spinal canal, it does not reduce blood loss from LamF decorticated transverse processes.

Adjacent level disease following lumbar spine surgery: A review.

Background:Instrumented lumbar spine surgery is associated with an increased risk of adjacent segment disease (ASD). Multiple studies have explored the various risk factors contributing to ASD that include; fusion length (especially, three or more levels), sagittal malalignment, facet injury, advanced age, and prior cephalad degenerative disease.Methods:In this selective review of ASD, following predominantly instrumented fusions for lumbar degenerative disease, patients typically underwent open versus minimally invasive surgery (MIS), transforaminal lumbar interbody fusions (TLIFs), posterior lumbar interbody fusions (PLIFs), or rarely posterolateral lumbar instrumented or noninstrumented fusions (posterolateral lumbar fusion).Results:The incidence of ASD, following open or MI lumbar instrumented fusions, ranged up to 30%; notably, the addition of instrumentation in different series did not correlate with improved outcomes. Alternatively, in one series, at 164 postoperative months, noninstrumented lumbar fusions reduced the incidence of ASD to 5.6% versus 18.5% for ASD performed with instrumentation. Of interest, dynamic instrumented/stabilization techniques did not protect patients from ASD. Furthermore, in a series of 513 MIS TLIF, there was a 15.6% incidence of perioperative complications that included; a 5.1% frequency of durotomy and a 2.3% instrumentation failure rate.Conclusions:The incidence of postoperative ASD (up to 30%) is greater following either open or MIS instrumented lumbar fusions (e.g., TLIF/PLIF), while decompressions with noninstrumented fusions led to a much smaller 5.6% risk of ASD. Other findings included: MIS instrumented fusions contributed to higher perioperative complication rates, and dynamic stabilization did not protect against ASD.

Incidence and management of cerebrospinal fluid fistulas in 336 multilevel laminectomies with noninstrumented fusions.

Background:The incidence (e.g., 3–27%) and the types of cerebrospinal fluid (CSF) fistulas occurring during multilevel lumbar laminectomy with noninstrumented spinal fusions varies.Methods:From 2000 to 2015, we retrospectively evaluated the incidence/etiologies of CSF fistulas occurring for 336 patients undergoing average 4.7 laminectomies with average 1.4 level noninstrumented fusions over a 15 year period. The varied etiologies of CSF leaks included; ossification of the yellow ligament (OYL) extending through the dura, postoperative surgical scar, iatrogenic traumatic leak, epidural steroid injections (ESI), resection of synovial cysts, and the removal of intradural tumors. Techniques for primary repairs included combinations of; 7-0 Gore-Tex (Newark, Delaware, USA) sutures, micro-dural staples, muscle patch/other (e.g., bovine pericardial) grafts, fibrin sealants/glues (e.g., Tisseel; Baxter International Inc., Westlake Village, CA, USA), and Duragen (Integra LifeSciences, Hawthorne, NY, USA) including both the thin and suturable types.Results:The etiologies of CSF fistulas in descending order included: Epidural spinal injections (ESI) (7 patients), synovial cysts (6 patients), OYL (5 patients), and equally for postoperative scar and intradural tumors (3 patients). CSF fistulas occurred in 24 (7.14%) of 336 patients; this frequency was reduced to 4.2% when ESI and intradural tumors were excluded.Conclusion:CSF fistulas occurred in 7.14% of 336 patients undergoing average 4.7 multilevel laminectomies with average 1.4 level noninstrumented fusions attributed to a lumbar stenosis with mild/moderate instability. The dural repair addressed seven prior ESI, six synovial cysts, five OYL, and operative scarring and intradural tumors (three apiece). Knowing the pathologies contributing to CSF fistulas should help the surgeon to better anticipate and treat these fistulas.

Surgery for Spinal Stenosis

Retrospective cohort analysis. To examine the complications, reoperation rates, and resource use after each of the surgical approaches for the treatment of spinal stenosis. There are no uniform guidelines for which procedure (decompression, decompression with instrumentation, or decompression with noninstrumented fusion) to perform for the treatment of spinal stenosis. With no clear evidence for increased efficacy, the rate of instrumented fusions is rising. We performed a retrospective cohort analysis of patients who underwent spinal stenosis surgery between 2002 and 2009 in the United States. Patients included (n = 12,657) were diagnosed with spinal stenosis without concurrent spondylolisthesis and had at least 2 years of preoperative enrollment. A total of 2385 patients with decompression only and 620 patients with fusion had follow-up data for 5 years or more. Complication rates during the initial procedure hospitalization and at 90 days were significantly higher for those who underwent laminectomy with fusion than for those who underwent laminectomy alone, with reoperation rates not differing significantly between these groups. Long-term (≥5 yr) reoperation rates were similar for those undergoing decompression alone versus decompression with fusion (17.3% vs. 16.0%, P = 0.44). Those with instrumented fusions had a slightly higher rate of reoperation than patients with noninstrumented fusions (17.4% vs. 12.2%, P = 0.11) at more than 5 years. The total cost including initial procedure and hospital, outpatient, emergency department, and medication charges at 5 years was similar for those who received decompression alone and fusion. The long-term costs for instrumented and noninstrumented fusions were also similar, totaling $107,056 and $100,471, respectively. For patients with spinal stenosis, if fusion is warranted, use of arthrodesis without instrumentation is associated with decreased costs with similar long-term complication and reoperation rates.

Tisseel utilized as hemostatic in spine surgery impacts time to drain removal and length of stay.

Background:Although fibrin sealants (FSs) and fibrin glues (FGs) are predominantly utilized to strengthen repairs of cerebrospinal fluid (CSF) fistulas (deliberate/traumatic) during spinal surgery, they are also increasingly utilized to achieve hemostasis. Here, we investigated whether adding Tisseel (Baxter International Inc., Westlake Village, CA, USA), utilized to address increased bleeding during multilevel lumbar laminectomies with non-instrumented fusions, would reduce or equalize the time to drain removal and length of stay (LOS) without contributing to infections or prolonging time to fusion.Methods:Prospectively, 39 patients underwent multilevel laminectomies and 1-2 level non-instrumented (in situ) fusions to address stenosis/olisthesis; 22 who demonstrated increased intraoperative bleeding received Tisseel, while 17 without such bleeding did not.Results:The 22 receiving versus 17 not receiving Tisseel, with similar clinical parameters, underwent comparable average multilevel laminectomies (4.36 and 4.25) and 1-2 level fusions (1.4 vs. 1.29 levels). As anticipated, for those receiving Tisseel, the average intraoperative estimated blood loss (EBL), total postoperative blood loss, and total perioperative transfusion requirements [red blood cells (RBC), fresh frozen plasma (FFP), platelets] were higher. However, Tisseel had the added benefit of equalizing the time to postoperative drain removal [e.g. 3.41 days (with) vs. 3.38 days (without)] and LOS [e.g. 5.86 days (with) vs. 5.82 days (without)] without increasing the infection rates (e.g. one superficial infection per group) or average times to fusion (e.g. 5.9 vs. 5.5 months).Conclusions:Adding Tisseel for increased bleeding during multilevel laminectomies/in situ fusions contributed to hemostasis by equalizing the average times to drain removal/LOS compared to patients without increased bleeding and not requiring Tisseel.

Commentary: Unnecessary preoperative epidural steroid injections lead to cerebrospinal fluid leaks confirmed during spinal stenosis surgery.

Background:Increasingly, older patients with severe spinal stenosis/instability undergo multiple unnecessary preoperative epidural spinal injections (ESI), despite their risks and lack of long-term benefits. Here we add to the list of risks by showing how often preoperative ESI lead to punctate cerebrospinal fluid (CSF) fistulas documented during subsequent surgery (e.g. multilevel laminectomies with non-instrumented fusions).Methods:A series of 39 patients with spinal stenosis/instability prospectively underwent multilevel laminectomy/non-instrumented fusion utilizing lamina autograft and NanOss Bioactive. We asked how often preoperative ESI were performed in this population and how frequently they contributed to operatively confirmed punctate cerebrospinal fluid (CSF) fistulas. Notably, CSF leaks were clearly attributed to ESI, as they were located centrally/paracentrally at the L4-L5 level, just below hypertrophied/ossified yellow ligament (OYL), and were the exact size of a Tuohy needle with clean edges.Results:An average of 4.1 (range 2-12) preoperative ESI were performed in 33 of 39 patients undergoing average 4.3 level laminectomies and 1.3 level non-instrumented fusions; 6 (18.2%) patients exhibited operatively confirmed, punctate CSF fistulas attributed to these ESI. The most recent injections were administered between 2 and 5 weeks prior to surgery (average 3.9 weeks). Fistulas were primarily repaired with 7-0 GORE-TEX sutures and fibrin Sealant (Tisseel).Conclusions:Of 33 patients undergoing multilevel laminectomies with non-instrumented fusions receiving preoperative ESI, 6 (18.2%) had operatively confirmed punctate CSF fistulas due to preoperative ESI performed an average of 4.1 times per patient.

Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials

Background contextChronic low back pain (cLBP) represents a major challenge to our health care systems. The relative efficacy of surgery over nonoperative treatment for the treatment of cLBP remains controversial, and little is known of the long-term comparative outcomes. PurposeTo compare the clinical outcome at long-term follow-up (LTFU) of patients who were randomized with either spinal fusion or multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP. Study design/settingLong-term clinical follow-up of three multicenter randomized controlled trials (RCTs) of surgery (instrumented or noninstrumented fusion, stabilization) versus nonoperative treatment (multidisciplinary cognitive-behavioral and exercise rehabilitation) in Norway and the United Kingdom. Patient sampleA total of 473 patients with cLBP of at least 1 year's duration who were all considered candidates for spinal fusion. Outcome measuresThe primary outcome was the Oswestry Disability Index (ODIv2.1a for the United Kingdom and ODIv1 for Norway) score measured at LTFU. Secondary outcomes included visual analog scale (VAS) pain intensity, pain frequency, pain medication use, work status, EuroQol VAS for health-related quality of life, satisfaction with care, and global treatment outcome at LTFU. MethodsPatients who consented to LTFU (average 11.4 [range 8–15] years after the initial treatment) completed the outcome questionnaires. ResultsOf 473 enrolled patients, 261 (55%) completed LTFU, 140/242 patients randomized to receive surgery and 121/231 randomized to receive multidisciplinary cognitive-behavioral and exercise rehabilitation. The intention-to-treat analysis showed no statistically or clinically significant differences between treatment groups for ODI scores at LTFU (adjusted for baseline ODI, previous surgery, duration of LBP, sex, age, and smoking habit): the mean adjusted treatment effect of fusion was −0.7 points on the 0–100 ODI scale (95% confidence interval [CI], −5.5 to 4.2). An as-treated analysis similarly demonstrated no advantage of surgery (treatment effect, −0.8 points on the ODI (95% CI, −5.9 to 4.3). The results for the secondary outcomes were largely consistent with those of the ODI, showing no relevant group differences. ConclusionsAfter an average of 11 years follow-up, there was no difference in patient self-rated outcomes between fusion and multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP. The results suggest that, given the increased risks of surgery and the lack of deterioration in nonoperative outcomes over time, the use of lumbar fusion in cLBP patients should not be favored in health care systems where multidisciplinary cognitive-behavioral and exercise rehabilitation programmes are available.

Early results of stand-alone anterior lumbar interbody fusion in iatrogenic spondylolisthesis patients

Iatrogenic spondylolisthesis is a challenging condition for spinal surgeons. Posterior surgery in these cases is complicated by poor anatomical landmarks, scar tissue adhesion of muscle and dural structures and difficult access to the intervertebral disc. Anterior interbody fusion provides an alternative treatment method, allowing indirect foraminal decompression, reliable disc clearance and implantation of large surface area implants. A retrospective chart review of patients with iatrogenic spondylolisthesis including pre- and post-operative Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores was performed. Imaging criteria were pelvic incidence, overall lumbar lordosis and segmental lordosis. In addition, the fusion rate was investigated after 6 months. Six consecutive patients treated between 2008 and 2011 (4 female, 2 male, mean age 61 ± 7.1 years) were identified. The initially performed surgeries included decompression with or without discectomy; posterior instrumented and non-instrumented fusion. The olisthetic level was in all cases at the decompressed level. All patients were revised with stand-alone anterior interbody fusion devices at the olisthetic level filled with BMP 2. Average ODI dropped from 49 ± 11 % pre-operatively to 26.0 ± 4.0 at 24 months follow-up. VAS average dropped from 7 ± 1 to 2 ± 0. Mean total lordosis of 39.8 ± 2.8° increased to 48.5 ± 4.9° at pelvic incidences of 48.8 ± 6.8° pre-operatively. Mean segmental lordosis at L4/5 improved from 10.5 ± 6.7° to 19.0 ± 4.9° at 24 months. Mean segmental lordosis in L5/S1 increased from 15.1 ± 7.4° to 23.2 ± 5.6°. Cage subsidence due to severe osteoporosis occurred in one case after 5 months, and hence there was no further follow-up. Fusion was confirmed in all other patients. Anterior interbody fusion offers good stabilisation and restoration of lordosis in iatrogenic spondylolisthesis and avoids the well-known problems associated with reentering the spinal canal for revision fusions. In this group, ODI and VAS scores were improved.

Safety of Thromboembolic Chemoprophylaxis in Spinal Trauma Patients Requiring Surgical Stabilization

Retrospective review. To determine the incidence of thromboembolic events, bleeding complications such as epidural hematomas, and wound complications in patients with spinal trauma requiring surgical stabilization. Literature addressing the safety and efficacy of chemoprophylactic agents in postoperative patients with spinal trauma is sparse. As a result, significant variability exists regarding administration of thromboembolic chemoprophylaxis in this population. The risk of bleeding complications is particularly concerning. Patients with spinal trauma who underwent surgical stabilization in 2009 and 2010 at a single level 1 trauma center were retrospectively reviewed. Exclusion criteria included patients who underwent solely decompressive procedures, noninstrumented fusions, kyphoplasty, or had incomplete medical records. Patients who received chemoprophylaxis were compared with patients who did not. Demographical information and injury data were collected. Primary outcome measures were prevalence of thromboembolic events, epidural hematomas, and persistent wound drainage requiring irrigation and debridement. Two hundred twenty-seven of 373 patients were included (56 in the untreated group, 171 in the treated group). Eight patients in the untreated group (14.3%) and 12 patients in the treated group (7%) developed postoperative thromboembolism (P = 0.096). There was 1 pulmonary embolism in the untreated group (1.8%), and 4 pulmonary embolisms in the treated group (2.3%). Surgical irrigation and debridement for wound drainage was required for 1.8% of patients in the untreated group and for 5.3% of patients in the treated group. No epidural hematomas were noted in either group. The treated group had more spinal levels fused (P = 0.46), higher injury severity scores (0.001), and longer hospitalizations (0.018). Patients who developed postoperative thromboembolism had significantly higher body mass indexes (P = 0.01), injury severity scores (0.001), number of spinal levels fused (P = 0.004), incidence of neurological deficits (0.001), and longer hospitalizations (0.16) compared with those who did not. The use of chemoprophylaxis appears to be safe in at-risk patients in the immediate postoperative period after spinal trauma surgery. No epidural hematomas occurred, and the risk of wound drainage is small. Body mass index, injury severity score, presence of neurological deficits, and number of spinal levels fused should be considered when determining which patients should receive chemoprophylaxis after surgical stabilization.

The evidence on surgical interventions for low back disorders, an overview of systematic reviews

Many systematic reviews have been published on surgical interventions for low back disorders. The objective of this overview was to evaluate the available evidence from systematic reviews on the effectiveness of surgical interventions for disc herniation, spondylolisthesis, stenosis, and degenerative disc disease (DDD). An earlier version of this review was published in 2006 and since then, many new, better quality reviews have been published. A comprehensive search was performed in the Cochrane database of systematic reviews (CDSR), database of reviews of effectiveness (DARE) and Pubmed. Two reviewers independently performed the selection of studies, risk of bias assessment, and data extraction. Included are Cochrane reviews and non-Cochrane systematic reviews published in peer-reviewed journals. The following conditions were included: disc herniation, spondylolisthesis, and DDD with or without spinal stenosis. The following comparisons were evaluated: (1) surgery vs. conservative care, and (2) different surgical techniques compared to one another. The methodological quality of the systematic reviews was evaluated using AMSTAR. We report (pooled) analyses from the individual reviews. Thirteen systematic reviews on surgical interventions for low back disorders were included for disc herniation (n = 6), spondylolisthesis (n = 2), spinal stenosis (n = 4), and DDD (n = 4). Nine (69 %) were of high quality. Five reviews provided a meta-analysis of which two showed a significant difference. For the treatment of spinal stenosis, intervertebral process devices showed more favorable results compared to conservative treatment on the Zurich Claudication Questionnaire [mean difference (MD) 23.2 95 % CI 18.5-27.8]. For degenerative spondylolisthesis, fusion showed more favorable results compared to decompression for a mixed aggregation of clinical outcome measures (RR 1.40 95 % CI 1.04-1.89) and fusion rate favored instrumented fusion over non-instrumented fusion (RR 1.37 95 % CI 1.07-1.75). For most of the comparisons, the included reviews were not significant and/or clinically relevant differences between interventions were identified. Although the quality of the reviews was quite acceptable, the quality of the included studies was poor. Future studies are likely to influence our assessment of these interventions.