An analysis of noninstrumented posterolateral lumbar fusions performed in predominantly geriatric patients using lamina autograft and beta tricalcium phosphate

BACKGROUND CONTEXT: The artificial bone-volume expander, beta tricalcium phosphate (B-TCP, Vitoss, OrthoVita, Malvern, PA), is increasingly used to supplement autograft in posterolateral lumbar fusions. PURPOSE: To determine fusion rates/outcomes using B-TCP/autograft. STUDY DESIGN/SETTING: Fusion rates and outcomes were assessed for 60 predominantly geriatric patients undergoing multilevel lumbar laminectomies and 1- to 2-level noninstrumented fusions using B-TCP/autograft. PATIENT SAMPLE: Patients on average were 70 years old. OUTCOME MEASURES: Odom's criteria and Short-Form 36 (SF-36) outcomes were studied 2 years postoperatively. METHODS: Sixty patients underwent an average of 5.4-level laminectomies with 1- to 2-level noninstrumented fusions. Based on dynamic X-ray/magnetic resonance/computed tomography (CT) studies, laminectomies addressed multilevel stenosis (60 patients), ossification of the yellow ligament (46 patients), disc herniations (20 patients), or synovial cysts (8 patients), and fusions addressed degenerative spondylolisthesis (48 patients), spondylolisthesis/lysis (2 patients), or degenerative scoliosis (10 patients). The fusion mass on each side contained half of all harvested autograft combined with one to 1.5 strips of B-TCP (saturated in 10cc of bone marrow aspirate/strip). Fusion rates were documented by two independent neuroradiologists using both dynamic X-rays, and thin-cut CT (2-dimensional/3-dimensional CT) studies obtained up to 2 years postoperatively. Odom's criteria and SF-36 outcomes were assessed over the same interval. RESULTS: Pseudarthrosis was documented in nine (15%) patients. Two years postoperatively, Odom's criteria revealed 28 excellent, 23 good, 5 fair, and 4 poor results, whereas SF-36 data revealed improvement on 6 of 8 Health Scales in all patients. CONCLUSIONS: A 15% pseudarthrosis rate followed multilevel laminectomy and 1- to 2-level noninstrumented posterolateral fusion using lamina autograft/B-TCP.     

A preliminary study of the efficacy of Beta Tricalcium Phosphate as a bone expander for instrumented posterolateral lumbar fusions

The associated morbidity of allograft(s) as bone graft expanders in spinal surgery has prompted the search for alternatives. The efficacy of Vitoss/Beta Tricalcium Phosphate (B-TCP: OrthoVita, Malvern PA, USA), an artificial bone substitute, combined with lamina autograft (50:50 mix) in 40 prospective posterolateral fusions utilizing pedicle/screw instrumentation was analyzed. Multilevel lumbar laminectomies (average 3.7 levels) were accompanied by 1 (27 patients) and 2 level (13 patients) fusions. Two neuroradiologists independently assessed fusion progression on dynamic x-rays and 2D-CT studies performed at 3, 6, and up to 12 months postoperatively. Outcomes were quantified utilizing Odom Criteria and Short-Form 36 (SF-36) questionnaires (preoperatively; and 3, 6, and 12 months postoperatively). By the sixth postoperative month, fusion was neuroradiologically confirmed on both dynamic x-rays and CT studies for 26 of 27 single level fusions (1 pseudarthrosis), and 11 of 13 two level fusions (L4-S1). Odom Criteria 3, 6, and 12 months postoperatively revealed continued improvement for all patients. SF-36 outcomes, however, revealed deterioration on 2 Health Scales (Role Physical, Role Emotional) 3 and 6 months post-operatively, and minimal to marked improvement on 6 Health Scales (PF, V, PF, V, SF, BP). Twelve months postoperatively improvement occurred on all 8 Health Scales, exceeding pre-operative baselines; minimal (RP, GH), mild (MH), moderate (PF, BP, V, SF), and marked improvement (RE). Although Vitoss/B-TCP and laminar autograft resulted in pseudarthrosis for 1 of 27 single level and 2 of 13 two level posterolateral instrumented lumbar fusions, only 1 of the latter patients required a secondary fusion.     

Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions

BackgroundBeta tricalcium phosphate (B-TCP) is increasingly used to supplement lamina autograft to perform posterolateral lumbar-instrumented arthrodesis.PurposeTo determine the radiographic arthrodesis and pseudarthrosis rates after multisegment lumbar laminectomies and one- or two-segment posterolateral instrumented fusion using lamina autograft and an artificial bone graft expander B-TCP (Vitoss; Orthovita, Malvern, PA, USA).Study design/settingTo document radiographic arthrodesis/pseudarthrosis rates using lamina autograft and B-TCP.Patient sampleOne hundred patients with lumbar spinal stenosis underwent multisegment laminectomies (average 3.6 segments) and one- (78 patients) or two- (22 patients) segment posterolateral instrumented arthrodesis.Outcome measuresTwo-year postoperative outcomes were assessed using Short-Form 36 questionnaires.MethodsThe arthrodesis mass consisted of lamina autograft and B-TCP. Two independent neuroradiologists, using both dynamic X-rays and 2D-CT studies performed 3, 4.5, 6, and up to 12 months postoperatively, documented radiographic arthrodesis progression.ResultsOne-segment arthrodesis was performed in 79 patients; 74 (93.7%) were radiographically fused “early” (6.5 postoperative months), 2 (2.5%) fused “late” (6.5–12 months), and 3 (3.8%) exhibited pseudarthrosis. Two-segment arthrodesis was performed in 21 patients; 14 (66.7%) radiographically fused “early,” 5 (23.8%) fused “late,” and 2 (9.5%) exhibited pseudarthrosis. Although chi-square analyses revealed a significant increase in the number of “late” radiographic fusions occurring for patients undergoing two-level arthrodesis, no significant difference in radiographic pseudarthrosis rates was noted between the two patient populations. In both groups, Short-Form 36 questionnaires revealed nearly comparable maximal improvement on seven of eight Health Scales by the second postoperative year.ConclusionsAt 6.5 months after multisegment lumbar laminectomies with posterolateral instrumented lumbar arthrodesis using lamina autograft/B-TCP, more one-segment (93.7%) versus two-segment (66.7%) radiographic arthrodesis occurred. By 1 year after operation, there was no significant difference in fusion rates between one- and two-segment radiographic arthrodeses.     

Fusion rates and SF-36 outcomes after multilevel laminectomy and noninstrumented lumbar fusions in a predominantly geriatric population

STUDY DESIGN: This study prospectively analyzed posterolateral fusion rates and Short-Form 36 (SF-36) outcomes after multilevel lumbar laminectomies and noninstrumented fusions. OBJECTIVE: SF-36 outcomes and posterolateral fusion rates were assessed. SUMMARY OF BACKGROUND DATA: Technologically advanced and expensive instrumentation techniques and fusion adjuncts (ie, bone morphogenetic protein) may not be necessary to achieve lumbar fusion in the geriatric population. Rather, noninstrumented fusions using lamina autograft and a bone volume expander may suffice. METHODS: Seventy-five patients averaging 69 years of age (49 females, 26 males) underwent average 4.9 level lumbar laminectomies with average 2.0 level noninstrumented posterolateral fusions using lamina autograft (average 30 cm) supplemented with demineralized bone matrix (average 30 cm) in a 50:50 mix. Two independent radiologists separately evaluated both 2-dimensional computed tomography (2D-CT) and dynamic x-ray data 3, 4.5, 6, and up to 12 months postoperatively; patients had to demonstrate fusion on both studies. Outcomes were assessed using the SF-36 questionnaire (preoperatively) 3, 6, 12, and 24 months postoperatively. Patients were followed an average of 3.3 years (minimum 2 y). RESULTS: Thirteen (17.3%) patients demonstrated pseudarthrosis as they had not fused on dynamic x-ray and/or 2D-CT studies an average of 5.6 months postoperatively. One patient required a secondary fusion. One and 2 years postoperatively, patients demonstrated nearly identical maximal improvement on 6 SF-36 Health Scales, but showed no real changes on General Health and Mental Health scales. CONCLUSIONS: Seventy-five predominantly geriatric patients underwent multilevel laminectomies with noninstrumented fusions using lamina autograft combined with a bone volume expander. Thirteen patients (17.3%) demonstrated pseudarthrosis on the basis of both dynamic x-ray and 2D-CT criteria; 1 patient required a second instrumented fusion. Moderate pseudarthrosis rates, a low reoperation rate, and satisfactory SF-36 outcomes were achieved using noninstrumented posterolateral fusions in a predominantly geriatric population.     

Posterolateral and anterior interbody spinal fusion models in the sheep

Posterolateral and anterior interbody spinal arthrodesis is a frequent procedure, but high nonunion rates are reported and harvesting autologous bone graft from the iliac crest significantly increases morbidity. Bone graft substitutes are an alternative, but to date clinical results are not conclusive. Bone substitutes can be organic or inorganic, biologic or synthetic. They can have osteoconductive properties, inductive properties or both. Animal experiments are essential to investigating bone substitutes using biomechanical and histologic methods not available in clinical studies. Few authors reported on instrumented anterior fusion models, but none used the sheep model. In the current study posterolateral and anterior interbody fusion models in sheep are described. Both models used instrumented fusions, applying porous mineral scaffolds, alone or mixed with bone. The surgical techniques are described step-by-step and potential difficulties are highlighted. Preliminary results are reported for the posterolateral fusion model using coralline graft substitutes. The coral granules mixed with locally harvested bone had fusion outcomes similar to pure autologous bone. The graft substitute showed marked resorption between 12 and 20 weeks. All fusions had bone cortex and good trabecular connectivity. Histologic evaluation suggests after 20 weeks nearly the entire surface of the substitute is covered with new bone. Porous mineral bone substitutes mixed with locally harvested autologous bone are thought to be a valid alternative for posterolateral fusions.     

The influence of lumbar lordosis on spinal fusion and functional outcome after posterolateral spinal fusion with and without pedicle screw instrumentation

The aim of the current study was to examine the correlation between lumbar lordosis, spinal fusion, and functional outcome in patients suffering from severe low back pain, treated by posterolateral spinal fusion with or without pedicle screw instrumentation. One hundred thirty patients were randomly allocated to posterolateral lumbar fusion with or without Cotrel-Dubousset instrumentation. Functional outcome was assessed preoperatively, and 1 and 2 years postoperatively. Lordosis angles of the lumbar spine and fusion rates were assessed at the 1- and 2-year follow-up. No difference in lordosis angle was found between the two groups at any time. Lordosis was unchanged at 2 years compared with preoperative status in both groups. In the instrumented group, nonunion (23%) was followed by a decrease in lordosis at follow-up (p < 0.05). However, in the noninstrumented group, nonunion (14%) resulted in increased lordosis (p < 0.05). No correlation was found between functional outcome and lordosis angle. The current study showed no correlation between functional outcome and lordosis angle either before or after posterolateral spinal fusion. Use of instrumentation did not influence lumbar spinal alignment compared with noninstrumented fusions. The sagittal alignment was stable both 1 and 2 years after solid fusion. The failure mode of instrumented fusions was a reduced degree of lordosis in contrast to an increased degree of lordosis in patients with noninstrumented fusion.     

A preliminary comparative study of radiographic results using mineralized collagen and bone marrow aspirate versus autologous bone in the same patients undergoing posterior lumbar interbody fusion with instrumented posterolateral lumbar fusion.

BACKGROUND CONTEXT: Multiple bone graft substitutes for spinal fusion have been studied with varying results. PURPOSE: The purpose of this study was to assess the effectiveness of a mineralized collagen matrix combined with bone marrow, versus autologous bone, in the same patients undergoing a posterior lumbar interbody fusion and an instrumented posterolateral lumbar fusion. STUDY DESIGN/SETTING: A prospective, comparative study. PATIENT SAMPLE: Patients indicated for one-level posterior lumbar interbody fusion and instrumented posterolateral lumbar fusion, serving as self-controls. OUTCOME MEASURES: Thin-cut computed tomographic scans with sagittal reconstruction and plain radiographs, including lateral flexion/extension views were performed and assessed at 12 and 24 months after surgery. Oswestry Disability Index and Visual Analog Scale questionnaires were completed by all patients preoperatively and at 12 and 24 months after surgery. METHODS: After informed consent and failure of nonoperative treatment, 25 consecutive patients requiring one-level instrumented posterolateral fusion combined with posterior interbody fusion were enrolled in the study. Mineralized collagen bone graft substitute combined with bone marrow aspirate was used on one side of the posterolateral fusion, with iliac crest autograft on the contralateral side. RESULTS: A fusion rate of 84% (21/25) was achieved for the autologous bone grafts and 80% (20/25) for the bone graft substitute. The interbody fusion rate was 92% (23/25). Mean Oswestry Disability Index (ODI) scores decreased 57.2% at 12 months and 55.6% at 24 months, compared with baseline. CONCLUSIONS: Mineralized collagen bone graft substitute exhibited similar radiographic results compared with autograft in this model. Further trials incorporating bilateral fusion, as well as posterolateral fusion alone without interbody fusion are warranted to confirm the results of this study.     

Instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to autologous bone.

BACKGROUND CONTEXT: Autogenous posterolateral fusion with and without instrumentation has been reported with good results. However, difficult-to-fuse patients, such as smokers, elderly patients with poor bone quality and/or quantity, or patients with prior posterior surgeries, may have somewhat lower fusion rates. PURPOSE: To determine the efficacy of coralline hydroxyapatite with or without demineralized bone matrix as a bone graft extender in a human clinical model with long-term follow-up. STUDY DESIGN/SETTING: A retrospective series of 40 patients undergoing instrumented autogenous posterolateral lumbar fusion augmented with coralline hydroxyapatite with or without demineralized bone matrix. PATIENT SAMPLE: Long-term clinical and radiographic follow-up were examined for 40 patients who underwent an instrumented posterolateral fusion only. Patients undergoing anterior lumbar interbody fusion (ALIF) procedures were not considered part of the sample. METHODS: All patients underwent successful transpedicular fixation with autogenous posterolateral lumbar fusion. Fifteen cc of Pro Osteon 500 coralline hydroxyapatite (Interpore Cross International, Irvine, CA) was used at each level. An additional 10 cc of Grafton demineralized bone matrix gel (Osteotech, Eatontown, NJ) was used in 70% of these patients. RESULTS: An overall fusion rate of 92.5% was achieved. Pain and function improvement were good but somewhat age dependent and correlated with the number of comorbidities. Patients with Grafton DBM gel had a lower fusion rate of 89.3%. CONCLUSIONS: Based on this small retrospective review, coralline hydroxyapatite is an effective bone graft extender in difficult-to-fuse patients as an adjunct to autologous bone for posterolateral fusion of the lumbar spine when combined with rigid instrumentation.     

Hydroxyapatite block for use in posterolateral lumbar fusion: a report of four cases

Autologous bone grafts for posterolateral lumbar fusion are harvested from the iliac crests. Recently, several alternatives to autologous bone have been evaluated (such as graft substitutes, graft extenders, or both) with variable results. However, no clinical long-term studies have validated the efficacy of these techniques in posterolateral lumbar fusion. This study evaluated radiographic and histologic findings in four patients (mean age, 66 years) during the first 5 years after posterolateral fusion with an hydroxyapatite block. The mean followup was 7 years 1 month. Radiologic evaluation was by plain radiographs and computed tomography scans. Histologic evaluation was done in one patient. Capillaries extended into the porous structure of the hydroxyapatite substrate, and some of the pores were replaced by newly formed bone tissue. The long-term results of graft substitutes were stable and hydroxyapatite appeared to have some potential to achieve union in posterolateral lumbar fusion. However, hydroxyapatite block alone has not functioned effectively as a complete graft substitute in posterolateral lumbar fusion. Thus, a suitable osteogenic material is required to induce the formation of new bone and achieve a solid union.     

Circumferential and posterolateral fusion for lumbar disc disease

Clinical outcome of low back fusion is unpredictable. There are various reports discussing the merits and clinical outcome of these two procedures. The patients were selected from a population of patients who had chronic low back pain unresponsive to conservative treatment. Thirty-six instrumented posterolateral fusions and 35 instrumented circumferential fusions with posterior lumbar interbody fusions were done simultaneously. Preoperative radiographic assessment included plain radiographs, magnetic resonance imaging scans, and provocative discography in all the patients. Posterolateral fusion or anterior lumbar interbody fusion was done for internal disc disruption. The Oswestry disability index, subjective scoring, and assessment of fusion were done at a minimum followup of 2 years. On subjective scoring assessment there was a satisfactory outcome of 63.9% (23 patients) in the posterolateral fusion group and 82.8% (29 patients) in the posterior lumbar interbody fusion group. On assessment by the Oswestry index no difference was found in outcome between the two groups. The posterolateral fusion group had a 63.9% satisfactory outcome and the posterior lumbar interbody fusion group had an 80% satisfactory outcome using the Oswestry disability index for postoperative assessment. There was 61.1% improvement in working ability in the posterolateral fusion group and 77.1% improvement in the posterior lumbar interbody fusion group which was not statistically significant. The authors consider instrumented circumferential fusion with posterior lumbar interbody fusion better than instrumented posterolateral fusion for managing chronic disabling low back pain.     

Autologous versus allogenic bone grafts in instrumented anterior cervical discectomy and fusion: a prospective study with respect to bone union pattern

Background The purpose of this prospective semi-randomised comparative study was to compare fusion rates, course of fusion, and occurrence of collapse and subsidence of autologous and allogenic bone grafts in instrumented anterior cervical fusion. The number of fused levels and the smoking status were investigated as potential factors influencing the bone-healing process. No similar prospective study on instrumented anterior cervical discectomy and fusion was found in the literature.Methods Seventy-nine consecutive patients were operated on using the Smith–Robinson technique with a single instrumentation system at one or two levels. Seventy-six cadaverous fibular bone grafts and 37 autologous iliac-crest bone grafts were inserted. All patients were followed up for at least 2 years.Results The radiographs obtained during the follow-up were analysed, and showed no statistical difference in fusion and collapse rate between autografts and allografts. Allografts showed significantly longer time to union. No case of graft migration was observed. No difference was found between fusion and collapse rate with respect to the number of fused levels in general, but greater time to union was seen in two-level fusions. When one- and two-level subgroups were compared, there was no evidence of any significant difference in fusion or collapse rates between autografts and allografts, and the healing process took longer in allogenic grafts. Smoking status did not alter any of the fusion or collapse rates, or the course of bone fusion.Conclusions This study demonstrates that allografts are suitable substitutes for autografts in instrumented ACDF. Prolonged time to union observed in allogenic bone grafts does not seem to be an important factor in instrumented procedures. Two-level grafting does not imply a significantly lower fusion rate, but longer time to union can be expected than with single-level instrumented procedures in both allograft and autograft subgroups. Our relatively small number of patients may not have been sufficient to decipher significant differences between smokers and non-smokers in the rate or course of fusion as previously reported.     

Open versus endoscopic lumbar pedicle screw fixation and posterolateral fusion in a sheep model: a feasibility study.

BACKGROUND CONTEXT: Conventional open procedures for lumbar pedicle screw instrumentation are often associated with significant morbidity resulting in longer postoperative recovery and hence have led to the advent of less invasive techniques of spinal instrumentation and fusion. PURPOSE: This study compares lumbar pedicle screw fixation and posterolateral fusion using endoscopic and open techniques in a sheep model. STUDY DESIGN: Endoscopic and open techniques of lumbar pedicle screw instrumentation and posterolateral fusion are compared in a sheep model (12 sheep in each group). The safety and fusion outcome are assessed by postoperative computed tomography (CT) scans performed at 6 months. METHODS: Twelve sheep underwent bilateral L4-L5 pedicle screw fixation and posterolateral fusion by means of endoscopic instrumentation and another 12 sheep by means of conventional open technique. For posterolateral fusions, an autologous iliac crest bone or bone graft substitute (Healos/MP52; Orquest, Mountain View, CA) was used on either the animal's left or right side. The animals were euthanized 6 months after surgery and the lumbar spines were harvested. Pedicle dimensions and screw insertion angles were measured and the two techniques were compared using CT and image analysis software. Pedicle screw misplacement was detected by means of direct inspection and CT scan, and fusions were evaluated by CT scans. RESULTS: The endoscopic group's screw insertion angle was more convergent, corresponded more closely to the human pedicle angle and was less variable than in the open technique. Three of the endoscopic group's 48 screws were misplaced medially, whereas in the open technique, 5 screws were misplaced laterally. Posterolateral bone fusion masses were palpable 6 months after surgery for both the autologous bone grafts and graft substitutes. There were no complications. The ratio of screw to pedicle diameter was approximately 0.6, greater than in human studies. CONCLUSIONS: Despite differences between pedicle dimensions and screw angles, most screws could be inserted into the sheep pedicle using endoscopic or open techniques. Bone fusion was successful in both groups. Thus, minimally invasive, endoscopic transpedicular screw-plate fixation and posterolateral fusion is feasible, and as effective as the conventional open technique.     

Hydroxyapatite-bioactive glass ceramic composite as stand-alone graft substitute for posterolateral fusion of lumbar spine: a prospective, matched, and controlled study

STUDY DESIGN: Prospective, matched, and controlled study. OBJECTIVE: To evaluate the efficacy of hydroxyapatite-bioactive glass ceramic composite (Chitra-HABg) as a stand-alone graft substitute in promoting posterolateral fusion in the lumbar spine as compared with autologous bone. BACKGROUND: The use of ceramics as stand-alone graft substitutes in posterolateral fusion remains controversial. The Chitra-HABg is a new composite that has undergone clinical trials in various orthopedic applications with excellent clinical and radiologic outcomes. METHODS: Twenty-four patients underwent instrumented posterolateral fusion, with Chitra-HABg laid on the left intertransverse bed and autogenous graft on the right side. The primary outcome measure was radiologic consolidation of the graft, and secondary outcome measures were the work status and the Modified Oswestry Disability index. The McNamara and Student chi test were applied for statistical analysis. RESULTS: Although the study was prematurely terminated owing to the high incidence of resorption of Chitra-HABg, 22 of the 24 subjects were followed-up for a minimum of 1 year. At the end of 1-year, excellent radiologic outcome was seen on the right side (autogenous graft) in all the cases, whereas 95% (21/22) of the cases had poor consolidation on the left side (Chitra-HABg). The clinical outcome was rated as good in 16/22 (73%) patients, fair in 5, and poor in only 1 patient, but this had no statistically significant association with the consolidation of the fusion mass. CONCLUSIONS: This study clearly demonstrates that hydroxyapatite-bioactive glass ceramic composites (Chitra-HABg) has no role as stand-alone bone graft substitutes in posterolateral fusion of the lumbar spine, as the composite undergoes resorption without the formation of bridging callus. LEVEL OF EVIDENCE: Level 1.     

The positive effect of posterolateral lumbar spinal fusion is preserved at long-term follow-up: a RCT with 11–13 year follow-up

Introduction Few studies have investigated the long-term effect of posterolateral lumbar spinal fusion on functional outcome. Aim To investigate the long-term result after posterolateral lumbar spinal fusion with and without pedicle screw instrumentation. Methods Questionnaire survey of 129 patients originally randomised to posterolateral lumbar spinal fusion with or without pedicle screw instrumentation. Follow-up included Dallas Pain Questionnaire (DPQ), Oswestry Disability Index (ODI), SF-36 and a question regarding willingness to undergo the procedure again knowing the result as global outcome parameter. Results Follow-up was 83% of the original study population (107 patients). Average follow-up time was 12 years (range 11–13 years). DPQ-scores were significantly lower than preoperatively in both groups (P < 0.005) and no drift towards the preoperative level was seen. No difference between the two groups were observed (instrumented vs. non-instrumented): DPQ Daily Activity mean 37.0 versus 32.0, ODI mean 33.4 versus 30.6, SF-36 PCS mean 38.8 versus 39.8, SF-36 MCS mean 49.0 versus 53.3. About 71% in both groups were answered positively to the global outcome question. Patients who had retired due to low back pain had poorer outcome than patients retired for other reasons, best outcome was seen in patients still at work (P = 0.01 or less in all questionnaires, except SF-36 MCS P = 0.08). Discussion Improvement in functional outcome is preserved for 10 or more years after posterolateral lumbar spinal fusion. No difference between instrumented fusion and non-instrumented fusion was observed. Patients who have to retired due to low back pain have the smallest improvement.     

Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery

BACKGROUND CONTEXTDue to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery.PURPOSETo evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft.STUDY DESIGNDouble-blind randomized clinical trial.PATIENT SAMPLEPatients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion.OUTCOME MEASURESVisual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D.METHODSOne hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as “fusion” or “no fusion.”RESULTSThere were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups.CONCLUSIONSPatients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.     

Posterolateral intertransverse lumbar fusion in a mouse model: surgical anatomy and operative technique.

BACKGROUND CONTEXT: Animal models are frequently used for studying the effect of bone graft substitutes or allogeneic materials on osterolateral lumbar fusion. Transgenic technology in the mouse provides a unique opportunity to further understand the biology of spine fusion. PURPOSE: To describe pertinent lumbar spine anatomy and formulate a surgical protocol for posterolateral fusion in the mouse model. STUDY DESIGN: Diagnostic model: development of an animal model for biologic evaluation of posterolateral spine fusion. METHOD: Ten mice were killed to study relevant lumbar spine anatomy and develop a protocol for lumbar spine fusion. The L4-L6 fusion protocol was validated in 46 mice for ease of exposure, preparation of the posterolateral fusion bed, introduction of bone inductive agents, and perioperative care. RESULTS: Anatomy and surgical technique for posterolateral intertransverse lumbar fusion in the mouse model are described. A paraspinal approach allows exposure of the transverse processes, decortication, and graft placement at the L4-L6 intertransverse fusion site. Decortication alone did not result in fusion, whereas the use of bone graft resulted in satisfactory fusion rates. Perioperative morbidity and mortality rates were low. CONCLUSION: The mouse posterolateral lumbar spine fusion model is reproducible, inexpensive, and has low complication rates. Knowledge of the relevant anatomy and adherence to a well-defined surgical protocol provides a reliable and reproducible experimental spine fusion model.     

New formulations of demineralized bone matrix as a more effective graft alternative in experimental posterolateral lumbar spine arthrodesis

STUDY DESIGN: A rabbit model of posterolateral intertransverse process spine arthrodesis was used. OBJECTIVE: To determine the efficacy of two new formulations of demineralized bone matrix. SUMMARY OF BACKGROUND DATA: The flowable gel form of Grafton (Osteotech, Eatontown, NJ) demineralized bone matrix has been shown to have osteoinductive properties in various models and currently is used clinically as bone graft material in posterolateral lumbar spine arthrodesis. Two new formulations of Grafton, one made of flexible sheets (Flex) and the other made in a malleable consistency (Putty), have improved handling characteristics compared with the gel form. METHODS: In this study, 108 New Zealand white rabbits underwent bilateral posterolateral intertransverse spine arthrodesis at L5-L6 using autogenous iliac crest bone graft alone (control), one of the new forms of demineralized bone matrix (DBM; made from rabbit bone) alone or in combination with autogenous iliac crest bone. Rabbits were killed 6 weeks after surgery. The lumbar spines were excised, and fusion success or failure was determined by manual palpation and radiography. Specimens also were processed for undecalcified histologic analysis. RESULTS: Manual palpation of the harvested lumbar spines revealed that the fusion rates of the Flex-DBM/Auto group (9/9, 100%) and Putty-DBM/Auto group (10/10, 100%) were superior (P < 0.01) to those of the Auto/control group (3/9, 33%). As a stand-alone graft substitute, Flex-DBM performed superiorly with a fusion rate of 11/11 (100%) compared with that of Putty-DBM (10/12, 83%) and Gel-DBM (7/12, 58%). The devitalized version of Flex-DBM had a fusion rate of 4/11 (36%), which was comparable with the devitalized Putty-DBM rate of 4/12 (33%). Both were superior (P < 0.05) to the devitalized Gel-DBM rate of 0/12 (0%). More mature fusions with greater amounts of trabecular bone were present radiographically and histologically in rabbits that received all forms of demineralized bone matrix than in those in which autograft was used. CONCLUSIONS: The new flexible sheet and malleable putty forms of demineralized bone matrix were effective as graft extender and graft enhancer in a model of posterolateral lumbar spine fusion. These newer formulations of Grafton appear to have a greater capacity to form bone than the gel form or autogenous bone graft alone in this model.     

The efficacy of autologous laminectomy bone combined with bone graft extenders in posterolateral lumbar instrumented fusion

Iliac crest autograft has been used successfully for many years in spinal fusion operations. The main advantages to iliac crest autograft are the easy accessibility, the robust combination of osteogenic, osteoinductive, and osteoconductive properties, and the resultant efficacy. However, autograft iliac crest bone graft has fallen out of favor in spinal fusion operations due to the morbidity associated with harvest. Various bone graft substitutes have become commercially available that provide similar fusion rates when compared to iliac crest autograft. None of the bone graft substitutes can match iliac crest bone graft in all 3 osteogenic, osteoinductive, and osteoconductive parameters, but when combined with local autologous laminectomy bone and, therefore, used as a bone graft extender, may very well come close. This article reviews the main categories of bone graft substitutes and extenders and the role of these substances when combined with local autologous laminectomy bone in posterolateral lumbar instrumented fusion operations.     

Pedicle fracture after instrumented posterolateral lumbar fusion: a case report

STUDY DESIGN: The case report of a 60-year-old man with late onset back pain after lumbar spine fusion is presented. OBJECTIVE: To report the rare complication of bilateral pedicle stress fractures after instrumented posterolateral lumbar fusion. SUMMARY OF BACKGROUND DATA: A 56-year-old man underwent revision spinal surgery for ongoing back pain secondary to pseudoarthroses. A posterolateral L4-S1 instrumented fusion using pedicle screws was performed. Autologous bone graft was applied to the decorticated lateral masses. The internal fixation was removed 2 years later, at which time plain radiographs showed that the fusion mass was solid. At the age of 60 years, the man presented with worsening back pain. Plain radiographs and computed tomographic scans demonstrated bilateral L4 pedicle stress fractures. A bone scan indicated that these were recent in origin. METHOD: The clinical assessment was undertaken by the senior author and surgeon. Investigations included plain radiography, computer tomography, and scintographic imaging. A systematic literature review of the relevant publications was performed. RESULTS: In the reported patient, bilateral pedicle stress fractures developed 2 years after pedicle screw removal from an L4-S1 instrumented posterolateral lumbar spine fusion. This occurred at the uppermost level of the fusion mass. CONCLUSIONS: The pedicle is the weakest point in the neural arch after posterolateral fusion. Although movement continues at the level of the disc space anteriorly, the pedicle is susceptible to fracture. Pedicle fracture is a rare late complication of posterolateral lumbar spine fusion.     

Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty

Retrospective cohort study of 1430 patients undergoing lumbar spinal fusion from 2002 - 2009. Objective: The goal of this study was to compare and evaluate the number of complications requiring reoperation in elderly versus younger patients. rhBMP-2 has been utilized off label for instrumented lumbar posterolateral fusions for many years. Many series have demonstrated predictable healing rates and reoperations. Varying complication rates in elderly patients have been reported. All patients undergoing instrumented lumbar posterolateral fusion of ≤ 3 levels consenting to utilization of rhBMP-2 were retrospectively evaluated. Patient demographics, body mass index, comorbidities, number of levels, associated interbody fusion, and types of bone void filler were analyzed. The age of patients were divided into less than 65 and greater than or equal to 65 years. Complications related to the performed procedure were recorded. After exclusions, 482 consecutive patients were evaluated with 42.1% males and 57.9% females. Average age was 62 years with 250 (51.9%) < 65 and 232 (48.1%) ≥ 65 years. Patients ≥ 65 years of age stayed longer (5.0 days) in the hospital than younger patients (4.5 days) (p=0.005). Complications requiring reoperation were: acute seroma formation requiring decompression 15/482, 3.1%, bone overgrowth 4/482, 0.8%, infection requiring debridement 11/482, 2.3%, and revision fusion for symptomatic nonunion 18/482, 3.7%. No significant differences in complications were diagnosed between the two age groups. Statistical differences were noted between the age groups for medical comorbidities and surgical procedures. Patients older than 65 years underwent longer fusions (2.1 versus 1.7 levels, p=0.001). Despite being older and having more comorbidities, elderly patients have similar complication and reoperation rates compared to younger healthier patients undergoing instrumented lumbar decompression fusions with rhBMP-2.