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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 15 - 15
1 Jan 2013
Patel M Newey M Sell P
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Background. The majority of studies assessing minimal clinical important difference in outcome do so for management of chronic low back pain. Those that identify MCID following spinal surgical intervention fail to differentiate between the different pathologies and treatments or use variable methods and anchors in the calculation. Aim. To identify the MCID in scores across the most common spinal surgical procedures using standardised methods of calculation. Method. Prospective longitudinal study following elective lumbar spinal surgery. All patients had a complete set of spinal outcome assessments (ODI and VAS) and self perceived rating of the global and Mcnab criteria. MCID was calculated as defined by Hagg et al. Results. 244 patients of average age 53 years were followed up for 62 months post surgery. The MCID across the range of spinal surgeries was a 10 point change in ODI and 28 points for the VAS. A MCID following lumbar decompression surgery was a 3 point change in ODI and 29 points for VAS; 24 points in ODI and 37 points in the VAS for a discectomy, and 13 points in ODI and 23 point change in VAS for revision surgery. This value also varied depending on the anchor and method used for calculation. Conclusion. The MCID in score varies between different spinal procedures, method of calculation and the external anchor used. Standardised methods of calculating MCID in outcome measures should be used to allow comparative research and assessment. Generalisation of MCID in scores across a range of spinal procedures should be strongly discouraged. Conflicts of Interest. None. Source of Funding. None. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 8 - 8
1 Apr 2013
Dunderdale CS Wellington K Khatri M
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Aim. To investigate the role of websites in enhancing patients' understanding of reason and risk of surgery as a part of informed consent for elective un-instrumented lumbar spine surgery (EULSS). Methodology. This was a National Research Ethical Committee approved RCT study. 63 patients underwent EULSS, out of which 14(29%) declined participation and 14(29%) were excluded. One did not have surgery therefore 34 were randomised to Standard (S) and intervention group (I) using sealed envelope. Standard group were given verbal information & leaflet while the Intervention group were given information on relevant section of . www.eurospine.org. and . www.spinesurgeons.ac.uk. websites. A 13 item Informed Consent Questionnaire (ICQ) was used to collect data. The primary outcomes were patients' perceived understanding of reason and risk of EULSS. Results. Average age was 54 (21–82) years, with similar demographics in both groups. Complete data was available for 20 (13 Standard and 7 Intervention group). No difference (χ. 2. = 0.42, df=1, p= 0.52) was observed on perception of reason and risk of surgery between two groups. Website usage increased from 30% to 50% in intervention group who continued to use the website. Conclusion. Website use appears to be useful to participants. Although support has not been found to accept the experimental hypothesis, valuable information has been gained that will serve to facilitate larger study to further explore the effectiveness of websites in enhancing of EULSS. No Conflict of interest. No funding obtained. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 19 - 19
1 Jul 2014
Hart R Komzák M Puskeiler M Jajtner P
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Background. Posterolateral fusion (PLF) is a commonly accepted surgical procedure and overall the most common technique performed to obtain fusion in the lumbar spine. Harvesting autologous bone from the iliac crest is associated with increased operation time, blood loss, and chronic donor site pain. Allograft material has an insufficient osteoinductive potential. Bone marrow concentrate (BMC) could be an option how to promote allograft PLF healing. The purpose of the presented study was to investigate the validity of BMC addition to allografts in instrumented lumbar PLF surgery. Methods. The study was prospective, randomised, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented (S. 4. , Aesculap, Tuttlingen, Germany) lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 × 10. 4. /L at average (range, 1.06–1.98 × 10. 4. /L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation. Results. In Group I at 12 months, the bone graft mass was assessed in X-rays as fused in no case (0 %) and at 24 months in 4 cases (10 %). In Group II, 6 cases (15 %) achieved fusion at 12 months and 14 cases (35 %) at 24 months. The statistically significant difference between both groups was proven for complete fusion at 12 months (p = 0.041) and at 24 months (p = 0.011), too. CT scans showed that 16 cases (40 %) in Group I and 32 cases (80 %) in Group II had evidence of at least unilateral continuous bridging bone between neighboring vertebrae at 24 months (p < 0.05). We have confirmed the hypothesis that the autologous BMC together with the allograft is a better alternative for the PLF than the allograft alone. Conclusions. The use of autologous MSCs in form of the BMC in combination with allograft is an effective option how to enhance the PLF healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 26 - 26
1 Apr 2013
Buisson Y McGregor A Strutton P
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Introduction. Changes in central nervous system (CNS) pathways controlling trunk and leg muscles in patients with low back pain(LBP) and lumbar radiculopathy have been observed and this study investigated whether surgery impacts upon these changes in the long term. Methods. 80 participants were recruited into the following groups: 25 surgery(S), 20 chronic LBP(CH), 14 spinal injection(SI), and 21 controls(C). Parameters of corticospinal control were examined before, at 6, 26 and 52 weeks following lumbar decompression surgery and equivalent intervals. Electromyographic(EMG) activity was recorded from tibialis anterior(TA), soleus(SOL), rectus abdominis(RA), external oblique(EO) and erector spinae(ES) muscles at the T12&L4 levels in response to transcranial magnetic stimulation of the motor cortex. Motor evoked potentials (MEP) and cortical silent periods(cSP) recruitment curves(RC) were analysed. Results. Trunk muscles in all patients had reduced raw EMG (P<0.001), increased motor thresholds (MTh;P<0.001) and MEP RC slopes. MTh in ESL4 correlated with back pain in all patients (r=0.201, P=0.016) and soleus MTh laterality with disability in surgery patients (r=0.49, P=0.018). S&SI patients displayed bilaterally increased soleus cSP (p<0.001), MEP latencies on the painful side (P<0.001), and cSP asymmetry (cSPA;P<0.001). cSPA resulted from abnormal soleus late responses on the painful side, indicating compromised agonist-antagonist control in patients with radiculopathy. In contrast to SI, surgery significantly reduced soleus cSPA and MEP latencies at 6 weeks (P≤0.034). Discussion. These results show long term changes in CNS control of trunk and leg muscles in radiculopathy and LBP, which are only partly reversed by surgery, and may provide future therapeutic targets to address the altered inhibitory processes within the brain. No conflicts of Interest. Sources of funding: The DISCS foundation. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 304 - 304
1 Jul 2014
Roh J Yeung C Field J
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Summary. In this study, OsteoAMP® bone graft showed superior fusion rates as compared to rhBMP-2 at all timepoints (p<0.004). Additionally, OsteoAMP® bone graft had >80% few adverse events as compared to rhBMP-2. Introduction. Adverse events and complications related to use of rhBMP-2 have raised many ethical, legal, and reimbursement concerns for surgeons. OsteoAMP® bone graft is an allograft derived growth factor, rich in osteoinductive, angiogenic, and mitogenic proteins. The following data displays a blinded, multi -center study evaluating and comparing fusion outcomes between rhBMP-2 and OsteoAMP® bone graft. Patients & Methods. A total of 254 consecutive patients (383 total levels) were treated with TLIF or LLIF spine fusion procedures. A group of 70 patients (53.3 ± 11.1 y/o) were treated with rhBMP-2 (Infuse®/Inductos®, Medtronic) and local bone inside of a PEEK interbody cage with an average of 1.44 levels per surgery. A group of 184 patients (60.5 ± 13.1 y/o) were treated with OsteoAMP® (Advanced Biologics) and local bone inside of a PEEK interbody cage with an average of 1.53 levels per surgery. Fusion assessments were made by a blinded independent radiologist based on radiograph and CT images at 6w, 3m, 6m, 12m, and 18m follow up. Radiographically evident adverse events were also assessed in a blinded manner by an independent radiologist. Results. Overall fusion analysis showed superiority in efficacy of OsteoAMP® over rhBMP-2 at all time points (p<0.004). Use of rhBMP-2 produced limited early fusions at 6 months (22.7%) yet improved at 1 year (71.4%). OsteoAMP® facilitated fusion for the majority of patients by 6 months (54.1%) and nearly all patients within 1 year (93.9%). At 18 months, 99.3% of OsteoAMP® patients had fused while the rhBMP-2 arm had an 86.7% fusion rate. Total time for fusion for OsteoAMP® was approximately half that of rhBMP-2 at 211.4 days and 407.1 days respectively. A subset cohort of 47 patients in the rhBMP-2 arm had OsteoAMP® packed anterior to the PEEK cage. When OsteoAMP® was used as an extender to rhBMP-2 in this manner, fusion rates increased at all timepoints (p=0.05 at 18 months) over patients that only had rhBMP-2 and local bone within the disc space. Though, the fusion rates of OsteoAMP® without rhBMP-2 remained higher than the rhBMP-2/local bone/OsteoAMP® extender cohort at all timepoints (p<0.05). To further isolate the effect of OsteoAMP, a subset cohort of 52 patients within the OsteoAMP® treatment arm in the absence of rhBMP-2 did not utilise bone marrow aspirate. The fusion rates of patients within this cohort was statistically higher at 6 months but did not show statistically higher fusion rates at 3 months, 12 months, or 18 months (p>0.12). When compared to the rhBMP-2 study arm, patients within the OsteoAMP® arm that did not receive bone marrow aspirate demonstrated higher fusion rates at all time points (p<0.04 at 12 and 18 months). The rhBMP-2 arm had more than 5 times the incidence of radiologically evident adverse events (osteolysis and ectopic bone formation) compared to the OsteoAMP® arm (43.3% vs. 8.2%, respectively). Discussion. Despite its use with an older patient population and a higher number of levels per surgery, OsteoAMP® has shown great promise as a faster and safer alternative to rhBMP-2 in lumbar spine surgery