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The Bone & Joint Journal
Vol. 96-B, Issue 2 | Pages 242 - 248
1 Feb 2014
Stundner O Chiu Y Sun X Ramachandran S Gerner P Vougioukas V Mazumdar M Memtsoudis SG

Despite the increasing prevalence of sleep apnoea, little information is available regarding its impact on the peri-operative outcome of patients undergoing posterior lumbar fusion. Using a national database, patients who underwent lumbar fusion between 2006 and 2010 were identified, sub-grouped by diagnosis of sleep apnoea and compared. The impact of sleep apnoea on various outcome measures was assessed by regression analysis. The records of 84 655 patients undergoing posterior lumbar fusion were identified and 7.28% (n = 6163) also had a diagnostic code for sleep apnoea. Compared with patients without sleep apnoea, these patients were older, more frequently female, had a higher comorbidity burden and higher rates of peri-operative complications, post-operative mechanical ventilation, blood product transfusion and intensive care. Patients with sleep apnoea also had longer and more costly periods of hospitalisation. . In the regression analysis, sleep apnoea emerged as an independent risk factor for the development of peri-operative complications (odds ratio (OR) 1.50, confidence interval (CI) 1.38;1.62), blood product transfusions (OR 1.12, CI 1.03;1.23), mechanical ventilation (OR 6.97, CI 5.90;8.23), critical care services (OR 1.86, CI 1.71;2.03), prolonged hospitalisation and increased cost (OR 1.28, CI 1.19;1.37; OR 1.10, CI 1.03;1.18). . Patients with sleep apnoea who undergo posterior lumbar fusion pose significant challenges to clinicians. . Cite this article: Bone Joint J 2014;96-B:242–8


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 53 - 61
1 Jan 2024
Buckland AJ Huynh NV Menezes CM Cheng I Kwon B Protopsaltis T Braly BA Thomas JA

Aims. The aim of this study was to reassess the rate of neurological, psoas-related, and abdominal complications associated with L4-L5 lateral lumbar interbody fusion (LLIF) undertaken using a standardized preoperative assessment and surgical technique. Methods. This was a multicentre retrospective study involving consecutively enrolled patients who underwent L4-L5 LLIF by seven surgeons at seven institutions in three countries over a five-year period. The demographic details of the patients and the details of the surgery, reoperations and complications, including femoral and non-femoral neuropraxia, thigh pain, weakness of hip flexion, and abdominal complications, were analyzed. Neurological and psoas-related complications attributed to LLIF or posterior instrumentation and persistent symptoms were recorded at one year postoperatively. Results. A total of 517 patients were included in the study. Their mean age was 65.0 years (SD 10.3) and their mean BMI was 29.2 kg/m. 2. (SD 5.5). A mean of 1.2 levels (SD 0.6) were fused with LLIF, and a mean of 1.6 (SD 0.9) posterior levels were fused. Femoral neuropraxia occurred in six patients (1.2%), of which four (0.8%) were LLIF-related and two (0.4%) had persistent symptoms one year postoperatively. Non-femoral neuropraxia occurred in nine patients (1.8%), one (0.2%) was LLIF-related and five (1.0%) were persistent at one year. All LLIF-related neuropraxias resolved by one year. A total of 32 patients (6.2%) had thigh pain, 31 (6.0%) were LLIF-related and three (0.6%) were persistent at one year. Weakness of hip flexion occurred in 14 patients (2.7%), of which eight (1.6%) were LLIF-related and three (0.6%) were persistent at one year. No patients had bowel injury, three (0.6%) had an intraoperative vascular injury (not LLIF-related), and five (1.0%) had ileus. Reoperations occurred in five patients (1.0%) within 30 days, 37 (7.2%) within 90 days, and 41 (7.9%) within one year postoperatively. Conclusion. LLIF involving the L4-L5 disc level has a low rate of persistent neurological, psoas-related, and abdominal complications in patients with the appropriate indications and using a standardized surgical technique. Cite this article: Bone Joint J 2024;106-B(1):53–61


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1347 - 1353
1 Oct 2009
Grob D Bartanusz V Jeszenszky D Kleinstück FS Lattig F O’Riordan D Mannion AF

In a prospective observational study we compared the two-year outcome of lumbar fusion by a simple technique using translaminar screws (n = 57) with a more extensive method using transforaminal lumbar interbody fusion and pedicular screw fixation (n = 63) in consecutive patients with degenerative disease of the lumbar spine. Outcome was assessed using the validated multidimensional Core Outcome Measures Index. Blood loss and operating time were significantly lower in the translaminar screw group (p < 0.01). The complication rates were similar in each group (2% to 4%). In all, 91% of the patients returned their questionnaire at two-years. The groups did not differ in Core Outcome Measures Index score reduction, 3.6 (. sd. 2.5) (translaminar screws) vs 4.0 (. sd. 2.8) (transforaminal lumbar interbody fusion) (p = 0.39); ‘good’ global outcomes, 78% (translaminar screws) vs 78% (transforaminal lumbar interbody fusion) (p = 0.99) or satisfaction with treatment, 82% (translaminar screws) vs 86% (transforaminal lumbar interbody fusion) (p = 0.52). The two fusion techniques differed markedly in their extent and the cost of the implants, but were associated with almost identical patient-orientated outcomes. Extensive three-point stabilisation is not always required to achieve satisfactory patient-orientated results at two years


The Bone & Joint Journal
Vol. 99-B, Issue 10 | Pages 1366 - 1372
1 Oct 2017
Rickert M Fleege C Tarhan T Schreiner S Makowski MR Rauschmann M Arabmotlagh M

Aims. We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). Materials and Methods. We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months. Results. At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups. Conclusion. Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: Bone Joint J 2017;99-B:1366–72


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 7 | Pages 955 - 960
1 Jul 2011
Tobler WD Ferrara LA

The presacral retroperitoneal approach for axial lumbar interbody fusion (presacral ALIF) is not widely reported, particularly with regard to the mid-term outcome. This prospective study describes the clinical outcomes, complications and rates of fusion at a follow-up of two years for 26 patients who underwent this minimally invasive technique along with further stabilisation using pedicle screws. The fusion was single-level at the L5-S1 spinal segment in 17 patients and two-level at L4–5 and L5-S1 in the other nine. The visual analogue scale for pain and Oswestry Disability Index scores were recorded pre-operatively and during the 24-month study period. The evaluation of fusion was by thin-cut CT scans at six and 12 months, and flexion-extension plain radiographs at six, 12 and 24 months. Significant reductions in pain and disability occurred as early as three weeks postoperatively and were maintained. Fusion was achieved in 22 of 24 patients (92%) at 12 months and in 23 patients (96%) at 24 months. One patient (4%) with a pseudarthrosis underwent successful revision by augmentation of the posterolateral fusion mass through a standard open midline approach. There were no severe adverse events associated with presacral ALIF, which in this series demonstrated clinical outcomes and fusion rates comparable with those of reports of other methods of interbody fusion


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 944 - 950
1 Jul 2017
Fan G Fu Q Zhang J Zhang H Gu X Wang C Gu G Guan X Fan Y He S

Aims. Minimally invasive transforaminal lumbar interbody fusion (MITLIF) has been well validated in overweight and obese patients who are consequently subject to a higher radiation exposure. This prospective multicentre study aimed to investigate the efficacy of a novel lumbar localisation system for MITLIF in overweight patients. Patients and Methods. The initial study group consisted of 175 patients. After excluding 49 patients for various reasons, 126 patients were divided into two groups. Those in Group A were treated using the localisation system while those in Group B were treated by conventional means. The primary outcomes were the effective radiation dosage to the surgeon and the exposure time. Results. There were 62 patients in Group A and 64 in Group B. The mean effective dosage was 0.0217 mSv (standard deviation (. sd. ) 0.0079) in Group A and 0.0383 mSv (. sd. 0.0104) in Group B (p <  0.001). The mean fluoroscopy exposure time was 26.42 seconds (. sd. 5.91) in Group A and 40.67 seconds (. sd. 8.18) in Group B (p < 0.001). The operating time was 175.56 minutes (. sd. 32.23) and 206.08 minutes (. sd. 30.15) (p < 0.001), respectively. The mean pre-operative localisation time was 4.73 minutes (. sd. 0.84) in Group A and 7.03 minutes (. sd. 1.51) in Group B (p < 0.001). The mean screw placement time was 47.37 minutes (. sd. 10.43) in Group A and 67.86 minutes (. sd. 14.15) in Group B (p < 0.001). The pedicle screw violation rate was 0.35% (one out of 283) in Group A and 2.79% (eight out of 287) in Group B (p = 0.020). Conclusion. The study shows that the localisation system can effectively reduce radiation exposure, exposure time, operating time, pre-operative localisation time, and screw placement time in overweight patients undergoing MITLIF. Cite this article: Bone Joint J 2017;99-B:944–50


The Bone & Joint Journal
Vol. 98-B, Issue 1 | Pages 109 - 116
1 Jan 2016
Chou P Ma H Liu C Wang S Lee OK Chang M Yu W

Methods

In this study of patients who underwent internal fixation without fusion for a burst thoracolumbar or lumbar fracture, we compared the serial changes in the injured disc height (DH), and the fractured vertebral body height (VBH) and kyphotic angle between patients in whom the implants were removed and those in whom they were not. Radiological parameters such as injured DH, fractured VBH and kyphotic angle were measured. Functional outcomes were evaluated using the Greenough low back outcome scale and a VAS scale for pain.

Results

Between June 1996 and May 2012, 69 patients were analysed retrospectively; 47 were included in the implant removal group and 22 in the implant retention group. After a mean follow-up of 66 months (48 to 107), eight patients (36.3%) in the implant retention group had screw breakage. There was no screw breakage in the implant removal group. All radiological and functional outcomes were similar between these two groups. Although solid union of the fractured vertebrae was achieved, the kyphotic angle and the anterior third of the injured DH changed significantly with time (p < 0.05).


Bone & Joint Research
Vol. 7, Issue 1 | Pages 28 - 35
1 Jan 2018
Huang H Nightingale RW Dang ABC

Objectives. Loss of motion following spine segment fusion results in increased strain in the adjacent motion segments. However, to date, studies on the biomechanics of the cervical spine have not assessed the role of coupled motions in the lumbar spine. Accordingly, we investigated the biomechanics of the cervical spine following cervical fusion and lumbar fusion during simulated whiplash using a whole-human finite element (FE) model to simulate coupled motions of the spine. Methods. A previously validated FE model of the human body in the driver-occupant position was used to investigate cervical hyperextension injury. The cervical spine was subjected to simulated whiplash exposure in accordance with Euro NCAP (the European New Car Assessment Programme) testing using the whole human FE model. The coupled motions between the cervical spine and lumbar spine were assessed by evaluating the biomechanical effects of simulated cervical fusion and lumbar fusion. Results. Peak anterior longitudinal ligament (ALL) strain ranged from 0.106 to 0.382 in a normal spine, and from 0.116 to 0.399 in a fused cervical spine. Strain increased from cranial to caudal levels. The mean strain increase in the motion segment immediately adjacent to the site of fusion from C2-C3 through C5-C6 was 26.1% and 50.8% following single- and two-level cervical fusion, respectively (p = 0.03, unpaired two-way t-test). Peak cervical strains following various lumbar-fusion procedures were 1.0% less than those seen in a healthy spine (p = 0.61, two-way ANOVA). Conclusion. Cervical arthrodesis increases peak ALL strain in the adjacent motion segments. C3-4 experiences greater changes in strain than C6-7. Lumbar fusion did not have a significant effect on cervical spine strain. Cite this article: H. Huang, R. W. Nightingale, A. B. C. Dang. Biomechanics of coupled motion in the cervical spine during simulated whiplash in patients with pre-existing cervical or lumbar spinal fusion: A Finite Element Study. Bone Joint Res 2018;7:28–35. DOI: 10.1302/2046-3758.71.BJR-2017-0100.R1


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 3 | Pages 359 - 364
1 Mar 2012
Pumberger M Chiu Y Ma Y Girardi FP Mazumdar M Memtsoudis SG

Increasing numbers of posterior lumbar fusions are being performed. The purpose of this study was to identify trends in demographics, mortality and major complications in patients undergoing primary posterior lumbar fusion. We accessed data collected for the Nationwide Inpatient Sample for each year between 1998 and 2008 and analysed trends in the number of lumbar fusions, mean patient age, comorbidity burden, length of hospital stay, discharge status, major peri-operative complications and mortality. An estimated 1 288 496 primary posterior lumbar fusion operations were performed between 1998 and 2008 in the United States. The total number of procedures, mean patient age and comorbidity burden increased over time. Hospital length of stay decreased, although the in-hospital mortality (adjusted and unadjusted for changes in length of hospital stay) remained stable. However, a significant increase was observed in peri-operative septic, pulmonary and cardiac complications. Although in-hospital mortality rates did not change over time in the setting of increases in mean patient age and comorbidity burden, some major peri-operative complications increased. These trends highlight the need for appropriate peri-operative services to optimise outcomes in an increasingly morbid and older population of patients undergoing lumbar fusion.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1717 - 1722
1 Dec 2020
Kang T Park SY Lee JS Lee SH Park JH Suh SW

Aims. As the population ages and the surgical complexity of lumbar spinal surgery increases, the preoperative stratification of risk becomes increasingly important. Understanding the risks is an important factor in decision-making and optimizing the preoperative condition of the patient. Our aim was to determine whether the modified five-item frailty index (mFI-5) and nutritional parameters could be used to predict postoperative complications in patients undergoing simple or complex lumbar spinal fusion. Methods. We retrospectively reviewed 584 patients who had undergone lumbar spinal fusion for degenerative lumbar spinal disease. The 'simple' group (SG) consisted of patients who had undergone one- or two-level posterior lumbar fusion. The 'complex' group (CG) consisted of patients who had undergone fusion over three or more levels, or combined anterior and posterior surgery. On admission, the mFI-5 was calculated and nutritional parameters collected. Results. Complications occurred in 9.3% (37/396) of patients in the SG, and 10.1% (19/167) of patients in the CG. In the SG, the important predictors of complications were age (odds ratio (OR) 1.036; p = 0.002); mFI-5 (OR 1.026 to 2.411, as score increased to 1 ≥ 2 respectively. ;. p = 0.023); albumin (OR 11.348; p < 0.001); vitamin D (OR 2.185; p = 0.032); and total lymphocyte count (OR 1.433; p = 0.011) . In the CG, the predictors of complications were albumin (OR 9.532; p = 0.002) and vitamin D (OR 3.815; p = 0.022). Conclusion. The mFI-5 and nutritional status were effective predictors of postoperative complications in the SG, but only nutritional status was successful in predicting postoperative complications in the CG. The complexity of the surgery, as well as the preoperative frailty and nutritional status of patients, should be considered when determining if it is safe to proceed with lumbar spinal fusion. Cite this article: Bone Joint J 2020;102-B(12):1717–1722


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Methods

An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.


The Bone & Joint Journal
Vol. 105-B, Issue 5 | Pages 543 - 550
1 May 2023
Abel F Avrumova F Goldman SN Abjornson C Lebl DR

Aims

The aim of this study was to assess the accuracy of pedicle screw placement, as well as intraoperative factors, radiation exposure, and complication rates in adult patients with degenerative disorders of the thoracic and lumbar spines who have undergone robotic-navigated spinal surgery using a contemporary system.

Methods

The authors reviewed the prospectively collected data on 196 adult patients who had pedicle screws implanted with robot-navigated assistance (RNA) using the Mazor X Stealth system between June 2019 and March 2022. Pedicle screws were implanted by one experienced spinal surgeon after completion of a learning period. The accuracy of pedicle screw placement was determined using intraoperative 3D fluoroscopy.


Bone & Joint Open
Vol. 5, Issue 8 | Pages 662 - 670
9 Aug 2024
Tanaka T Sasaki M Katayanagi J Hirakawa A Fushimi K Yoshii T Jinno T Inose H

Aims

The escalating demand for medical resources to address spinal diseases as society ages is an issue that requires careful evaluation. However, few studies have examined trends in spinal surgery, especially unscheduled hospitalizations or surgeries performed after hours, through large databases. Our study aimed to determine national trends in the number of spine surgeries in Japan. We also aimed to identify trends in after-hours surgeries and unscheduled hospitalizations and their impact on complications and costs.

Methods

We retrospectively investigated data extracted from the Diagnosis Procedure Combination database, a representative inpatient database in Japan. The data from April 2010 to March 2020 were used for this study. We included all patients who had undergone any combination of laminectomy, laminoplasty, discectomy, and/or spinal arthrodesis.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 422 - 430
15 Mar 2023
Riksaasen AS Kaur S Solberg TK Austevoll I Brox J Dolatowski FC Hellum C Kolstad F Lonne G Nygaard ØP Ingebrigtsen T

Aims

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort.

Methods

This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 809 - 817
27 Sep 2024
Altorfer FCS Kelly MJ Avrumova F Burkhard MD Sneag DB Chazen JL Tan ET Lebl DR

Aims

To report the development of the technique for minimally invasive lumbar decompression using robotic-assisted navigation.

Methods

Robotic planning software was used to map out bone removal for a laminar decompression after registration of CT scan images of one cadaveric specimen. A specialized acorn-shaped bone removal robotic drill was used to complete a robotic lumbar laminectomy. Post-procedure advanced imaging was obtained to compare actual bony decompression to the surgical plan. After confirming accuracy of the technique, a minimally invasive robotic-assisted laminectomy was performed on one 72-year-old female patient with lumbar spinal stenosis. Postoperative advanced imaging was obtained to confirm the decompression.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims

Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.

Methods

As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients.


The Bone & Joint Journal
Vol. 104-B, Issue 12 | Pages 1343 - 1351
1 Dec 2022
Karlsson T Försth P Skorpil M Pazarlis K Öhagen P Michaëlsson K Sandén B

Aims

The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion.

Methods

The Swedish Spinal Stenosis Study (SSSS) was conducted between 2006 and 2012 at five public and two private hospitals. Six centres participated in this two-year MRI follow-up. We randomized 222 patients with central lumbar spinal stenosis at one or two adjacent levels into two groups, decompression alone and decompression with fusion. The presence or absence of a preoperative spondylolisthesis was noted. A new stenosis on two-year MRI was used as the primary outcome, defined as a dural sac cross-sectional area ≤ 75 mm2 at the operated level (restenosis) and/or at the level above (proximal adjacent level stenosis).


The Bone & Joint Journal
Vol. 97-B, Issue 10 | Pages 1411 - 1416
1 Oct 2015
Li Y Yang S Chen H Kao Y Tu Y

We evaluated the impact of lumbar instrumented circumferential fusion on the development of adjacent level vertebral compression fractures (VCFs). Instrumented posterior lumbar interbody fusion (PLIF) has become a popular procedure for degenerative lumbar spine disease. The immediate rigidity produced by PLIF may cause more stress and lead to greater risk of adjacent VCFs. However, few studies have investigated the relationship between PLIF and the development of subsequent adjacent level VCFs. . Between January 2005 and December 2009, a total of 1936 patients were enrolled. Of these 224 patients had a new VCF and the incidence was statistically analysed with other covariants. In total 150 (11.1%) of 1348 patients developed new VCFs with PLIF, with 108 (72%) cases at adjacent segment. Of 588 patients, 74 (12.5%) developed new subsequent VCFs with conventional posterolateral fusion (PLF), with 37 (50%) patients at an adjacent level. Short-segment fusion, female and age older than 65 years also increased the development of new adjacent VCFs in patients undergoing PLIF. In the osteoporotic patient, more rigid fusion and a higher stress gradient after PLIF will cause a higher adjacent VCF rate. Cite this article: Bone Joint J 2015;97-B:1411–16


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 3 | Pages 342 - 345
1 Mar 2007
Vaidya R Weir R Sethi A Meisterling S Hakeos W Wybo CD

We carried out a prospective study to determine whether the addition of a recombinant human bone morphogenetic protein (rhBMP-2) to a machined allograft spacer would improve the rate of intervertebral body fusion in the spine. We studied 77 patients who were to undergo an interbody fusion with allograft and instrumentation. The first 36 patients received allograft with adjuvant rhBMP-2 (allograft/rhBMP-2 group), and the next 41, allograft and demineralised bone matrix (allograft/demineralised bone matrix group). Each patient was assessed clinically and radiologically both pre-operatively and at each follow-up visit using standard methods. Follow-up continued for two years. Every patient in the allograft/rhBMP-2 group had fused by six months. However, early graft lucency and significant (> 10%) subsidence were seen radiologically in 27 of 55 levels in this group. The mean graft height subsidence was 27% (13% to 42%) for anterior lumbar interbody fusion, 24% (13% to 40%) for transforaminal lumbar interbody fusion, and 53% (40% to 58%) for anterior cervical discectomy and fusion. Those who had undergone fusion using allograft and demineralised bone matrix lost only a mean of 4.6% (0% to 15%) of their graft height. Although a high rate of fusion (100%) was achieved with rhBMP-2, significant subsidence occurred in more than half of the levels (23 of 37) in the lumbar spine and 33% (6 of 18) in the cervical spine. A 98% fusion rate (62 of 63 levels) was achieved without rhBMP-2 and without the associated graft subsidence. Consequently, we no longer use rhBMP-2 with allograft in our practice if the allograft has to provide significant structural support