A novel EP4 selective agonist (KMN-159) was developed [1] and has been proven that it can act as an osteopromotive factor to repair critical-size femoral bone defects in rats at a dose-dependent manner [2]. Based on its osteopromotive properties, we hypothesized that KMN-159 could also aid in bone formation for spinal fusion. Therefore, the aim of this study was to investigate its spinal fusion effect in a dorsolateral spinal fusion model in rats. This study was performed on 192, 10-week-old male Wistar rats. The rats were randomized into 8 groups (n = 12 per group): 1) SHAM (negative control), 2) MCM (scaffold only), 3) MCM + 20 µg BMP-2 (positive control), 4-8) MCM + 0.2, 2, 20, 200 or 2000 µg KMN-159. A posterolateral intertransverse process spinal fusion at L4 to L5 was performed bilaterally by implanting group dependent scaffolds (see above) or left empty in the SHAM group (protocol no. 25-5131/474/38). Animals were euthanized after 3 weeks and 6 weeks for µCT and biomechanical testing analysis. The results showed that KMN-159 promoted new bone formation in a dose-dependent manner at 3 weeks and 6 weeks as verified by µCT. The biomechanical testing showed that the dose of 20, 200 and 2000 µg KMN-159 groups obtained comparable strength with BMP-2 group, which higher than SHAM, MCM and lower doses of 0.2 and 2 µg KMN-159 groups. In conclusion, KMN-159 could be a potential replacement of BMP-2 as a novel osteopromotive factor for spinal fusion. Acknowledgements: We are grateful to Ulrike Heide, Anna-Maria Placht (assistance with surgeries) as well as Suzanne Manthey & Annett Wenke (histology)

Background. Current clinical treatment for spinal instability requires invasive spinal fusion with cages and screw instrumentation. We previously reported a novel injectable hydrogel (Bgel), which supports the delivery and differentiation of mesenchymal stem cells (MSCs) to bone forming cells and supports bone formation in vivo. Here, we investigated whether this system could be utilised to induce bone formation within intervertebral disc tissue as a potential injectable spinal fusion approach. Methodology. Bovine and Human Nucleus pulpous tissue explants were injected with Bgel with and without MSCs. Tissue samples were cultured under hypoxia (5%) in standard culture media for 4 weeks. Cell viability, histological assessment of matrix deposition, calcium formation, and cell phenotype analysis using immunohistochemistry for NP matrix and bone markers. Results. Following injection of B-gel into tissue explants following culture for 4 weeks, cells were visualized within the regions of the B-gel. Demonstrating that native cells were able to migrate into regions of B-gel. Increased collagen deposition was seen in tissue explants injected with Bgel, with increased collagen type I and X but decreased collagen type II staining in explants injected with Bgel. Tissue explants, in the absence of Bgel, showed limited calcium deposition, which was increased in B-gel injected explants. Furthermore, disc cells increased expression of bone markers (alkaline phosphatase & osteocalcin), but decreased NP matrix (Aggrecan and Collagen type II) following Bgel injection. Conclusion. This system could have potential to support spinal fusion via direct injection into the disc. Conflict of interest: C Le Maitre & C Sammon are inventors on the hydrogel discussed. Funding: This work was funded by GrowMed Tech Proof of Concept funding

Although bone morphogenetic protein 2 (BMP-2) has been FDA-approved for spinal fusion for decades, its disadvantages of promoting osteoclast-based bone resorption and suboptimal carrier (absorbable collagen sponge) leading to premature release of the protein limit its clinical applications. Our recent study showed an excellent effect on bone regeneration when BMP-2 and zoledronic acid (ZA) were co-delivered based on a calcium sulphate/hydroxyapatite (CaS/HA) scaffold in a rat critical-size femoral defect model. Therefore, the aim of this study was to evaluate whether local application of BMP-2 and ZA released from a CaS/HA scaffold is favorable for spinal fusion. We hypothesized that CaS/HA mediated controlled co-delivery of rhBMP-2 and ZA could show an improved effect in spinal fusion over BMP-2 alone. 120, 8-week-old male Wistar rats (protocol no. 25-5131/474/38) were randomly divided into six groups in this study (CaS/HA, CaS/HA + BMP-2, CaS/HA + systemic ZA, CaS/HA + local ZA, CaS/HA + BMP-2 + systemic ZA, CaS/HA + BMP-2 + local ZA). A posterolateral spinal fusion at L4 to L5 was performed bilaterally by implanting group-dependent scaffolds. At 3 weeks and 6 weeks, 10 animals per group were euthanized for µCT, histological staining, or mechanical testing. µCT and histological results showed that the CaS/HA + BMP-2 + local ZA group significantly promoted bone regeneration than other treated groups. Biomechanical testing showed breaking force in CaS/HA + BMP + local ZA group was significantly higher than other groups at 6 weeks. In conclusion, the CaS/HA-based biomaterial functionalized with bioactive molecules rhBMP-2 and ZA enhanced bone formation and concomitant spinal fusion outcome. Acknowledgements: Many thanks to Ulrike Heide, Anna-Maria Placht (assistance with surgeries) as well as Suzanne Manthey & Annett Wenke (histology)

Spinal diseases such as unstable fractures, infections, primary or secondary tumors or deformities require surgical stabilization with implants. The long-term success of this treatment is only ensured by a solid bony fusion. The size of the bony defect, the often poor bone quality and metabolic diseases increase the risk of non-union and make the case a great burden for the patient and a challenge for the surgeon. The goal of spinal fusion can only be achieved if the implants used offer sufficient mechanical stability and the local biological regeneration potential is large enough to form sufficient bone. The lecture will present challenging clinical cases. In addition, implant materials and new surgical techniques are discussed. Local therapeutic effects are achieved through the release of osteopromotive or anti-resorbtive drugs, growth factors and antibiotics. By influencing biological pathways, basic orthopedic research has strong potential to further positively change future spinal surgery

Hip instability is one of the most common causes for total hip arthroplasty (THA) revision surgery. Studies have indicated that lumbar fusion (LF) surgery is a risk factor for hip dislocation. Instrumented spine fusion surgery decreases pelvic tilt, which might lead to an increase in hip motion to accommodate this postural change. To the best of our knowledge, spine-pelvis-hip kinematics during a dynamic activity in patients that previously had both a THA and LF have not been investigated. Furthermore, patients with a combined THA and LF tend to have greater disability. The purpose was to examine spine-pelvis-hip kinematics during a sit to stand task in patients that have had both THA and LF surgeries and compare it to a group of patients that had a THA with no history of spine surgery. The secondary purpose was to compare pain, physical function, and disability between these patients. This cross-sectional study recruited participants that had a combined THA and LF (n=10; 6 females, mean age 73 y) or had a THA only (n=11; 6 females, mean age 72 y). Spine, pelvis, and hip angles were measured using a TrakSTAR motion capture system sampled at 200 Hz. Sensors were mounted over the lateral thighs, base of the sacrum, and the spinous process of the third lumbar,12th thoracic, and ninth thoracic vertebrae. Participants completed 10 trials of a standardized sit-to-stand-to-sit task. Hip, pelvis, lower lumbar, upper lumbar, and lower thoracic sagittal joint angle range of motion (ROM) were calculated over the entire task. In addition, pain, physical function, and disability were measured with clinical outcomes: Hip Disability Osteoarthritis Outcome Score (pain and physical function), Oswestry Low Back Disability Questionnaire (disability), and Harris Hip Score (pain, physical function, motion). Physical function performance was measured using 6-Minute Walk Test, Stair Climb Test, and 30s Chair Test. Angle ROMs during the sit-to-stand-to-sit task and clinical outcomes were compared between THA+LF and THA groups using independent t-tests and effect sizes (d). The difference in hip ROM was approaching statistical significance (p=0.07). Specifically, the THA+LF group had less hip ROM during the sit-to-stand-to-sit task than the THA only group (mean difference=11.17, 95% confidence interval=-1.13 to 23.47), which represented a large effect size (d=0.83). There were no differences in ROM for pelvis (p=0.54, d=0.28) or spinal (p=0.14 to 0.97; d=0.02 to 0.65) angles between groups. The THA+LF group had worse clinical outcomes for all measures of pain, physical function, and disability (p=0.01 to 0.06), representing large effect sizes (d=0.89 to 2.70). Hip ROM was not greater in the THA+LF group, and thus this is unlikely a risk factor for hip dislocation during this specific sit-to-stand-to-sit task. Other functional tasks that demand greater excursions in the joints should be investigated. Furthermore, the lack of differences in spinal and pelvis ROM were likely due to the task and the THA+LF group had spinal fusions at different levels. Combined THA+LF results in worse clinical outcomes and additional rehabilitation is required for these patients

Biphasic calcium phosphate (BCP) with a characteristic needle-shaped submicron surface topography (MagnetOs) has attracted much attention due to its unique bone-forming ability which is essential for repairing critical-size bone defects such as those found in the posterolateral spine. Previous in vitro and ex-vivo data performed by van Dijk LA and Yuan H demonstrated that these specific surface characteristics drive a favorable response from the innate immune system. This study aimed to evaluate and compare the in vivo performance of three commercially-available synthetic bone grafts, (1) i-FACTOR Putty. ®. , (2) OssDsign. ®. Catalyst Putty and (3) FIBERGRAFT. ®. BG Matrix, with that of a novel synthetic bone graft in a clinically-relevant instrumented sheep posterolateral lumbar spine fusion (PLF) model. The novel synthetic bone graft comprised of BCP granules with a needle-shaped submicron surface topography (MagnetOs) embedded in a highly porous and fibrillar collagen matrix (MagnetOs Flex Matrix). Four synthetic bone grafts were implanted as standalone in an instrumented sheep PLF model for 12 weeks (n=3 bilateral levels per group; levels L2/3 & L4/5), after which spinal fusion was determined by manual palpation, radiograph and µCT imaging (based on the Lenke scale), range-of-motion mechanical testing, and histological and histomorphological evaluation. Radiographic fusion assessment determined bilateral robust bone bridging (Lenke scale A) in 3/3 levels for MagnetOs Flex Matrix compared to 1/3 for all other groups. For µCT, bilateral fusion (Lenke scale A) was found in 2/3 levels for MagnetOs Flex Matrix, compared to 0/3 for i-FACTOR Putty. ®. , 1/3 for OssDsign. ®. Catalyst Putty and 0/3 for FIBERGRAFT. ®. BG Matrix. Fusion assessment for MagnetOs Flex Matrix was further substantiated by histology which revealed significant graft resorption complemented by abundant bone tissue and continuous bony bridging between vertebral transverse processes resulting in bilateral spinal fusion in 3/3 implants. These results show that MagnetOs Flex Matrix achieved better fusion rates compared to three commercially-available synthetic bone grafts when used as a standalone in a clinically-relevant instrumented sheep PLF model

Cervical and lumbar spine fusion procedures are increasing every year. Nonetheless, these procedures are associated with high infection rates, resulting in additional cost burden. The conundrum of achieving efficient spinal fusions with minimum complications requires an ideal bone graft with osteoconductive, osteoinductive, osteogenic and structural characteristics. Synthetic bone graft substitutes with or without autograft, allograft or synthetic bone substitutes have been commonly used for fusion procedures. We carried out a meta-analysis of comparative studies and prospective case series (n = 29) with cervical and lumbar fusion procedures using synthetic bone graft substitutes, autograft or allograft and other biologics. Synthetic bone graft substitutes analysed included HA (Hydroxyapatite), β-TPC (Tri Calcium Phosphate), β-TSC (Tri Calcium Sulfate), PMMA (Polymethylmetacrylate), Surgibone, BOP (Biocompatible Osteoconductive Polymer). The analysis revealed suboptimal evidence for the efficacy and safety of synthetic products used in spinal fusion procedures. Further studies are needed to determine beneficial effects of synthetic substitutes. However, the infection rate could be highly decreased with surface and composition modification of widely used polyether ether ketone (PEEK) implants. Laser modification of surface characteristics and collagen fleeces with micro and nano pore structures can prove to be excellent surface for increased osteoblasts cell proliferation and vitality

Spinal fusion is one of the most common surgical procedures in spine surgery, whose primary objective is the stabilization of the spine for the treatment of many degenerative, traumatic and oncological diseases of the spine. Autologous bone is still considered the “gold standard” technique for spinal fusion. However, biomaterials which are potentially osteogenic, osteoinductive and osteoconductive can be used to increase the process of spinal fusion. We evaluated two new bone substitutes as an alternative to autologous bone for spinal fusion, using an animal model of large size (adult sheep). A preclinical study was designed to compare the efficacy of SINTlife® Putty and DBSINT® biomaterials with conventional bone autograft in an ovine model of lumbar spine fusion. SINTlife® is a biomaterial made from hydroxyapatite enriched with magnesium ions, resulting to be very similar to natural bone. DBSint® is a paste composite bone, osteo-inductive, pliable and conformable, consisting of demineralized bone matrix (DBM) carried by hydroxyapatite biomimetics. Eighteen adult female sheep were selected for two-levels spine surgical procedures. The animals were divided in two groups: in Group A, one fusion level was treated with SINTlife® Putty and the other level received cortical-cancellous bone autograft; in Group B, one fusion level was treated with DBSINT® and the other level received cortical-cancellous bone autograft. At the end of the experimental time, all the animals were euthanized. The spine segments were analyzed macroscopically, radiographically, microtomographically, histologically and histomorphometrically. The SINT-Life® Putty shows a perfect osteointegration in all the histological specimens. A high percentage of newly formed bone tissue is detected, with lots of trabeculae having structure and morphology similar to the pre-existing bone. In all the specimens collected from DBSINT®-treated animals the presence of hydroxyapatite alone is reported but not the demineralized bone matrix. The presence of newly formed bone tissue can be detected in all the specimens but newly formed bone shows very thin and irregular trabeculae next to the cartilage zone, while away from the border of ossification there are thicker trabeculae similar to the pre-existing bone. The use of the experimental biomaterial SINT-Life® Putty in an ovine model of spine fusion leads to the development of newly formed bone tissue without qualitative and quantitative differences with the one formed with autologous bone. The experimental material DBSINT® seems to lead to less deposition of newly formed bone with wider intertrabecular spaces. Following these results, we planned and submitted to the Ethical Committee a clinical study to evaluate the safety and efficacy of SINT-Life® product in comparison to autologous bone, as an alternative treatment for spine fusion procedures

Introduction. There is growing evidence that patients with lumbar spine fusion are at greater risk for postoperative dislocation following total hip arthroplasty. The purpose of this study is to review one author's experience with the modified direct lateral approach in patients with prior or subsequent lumbar spine fusion and total hip arthroplasty. Methods. Our IRB approved clinical database was queried for all primary total hip arthroplasties performed by the senior author from 1/1/2004 to 12/31/2016. All were performed via a modified direct lateral approach. Of these 1902 hips (1656 patients), 59 were identified in our medical records as patients who had a prior spine fusion or a spine fusion following THA. The extent of fusion was identified and reported. Radiographs were reviewed for acetabular position (abduction and anteversion) and leg length discrepancies. Records were reviewed and patients were contacted to determine if there were dislocations. Results. Of the 59 patients with concomitant spine fusion and total hip arthroplasty, 47 had the fusion prior to THA and 12 following THA. All patients were seen in the office or contacted by phone for a mean follow up of 5.8 years (2 to 15 years)(3 deceased, 3 lost). The direct lateral approach was used in all cases and in no cases was a dual mobility, lipped liner, or constrained component used. Head size ranged from 32 to 40. There were no postoperative dislocations in any of these patients. Acetabular position was a mean 43.6 degrees abduction (range 30–50), and a mean anteversion of 23.7 degrees (range 17 – 34). Average postoperative LLD was 2.8mm long on operated side (range −2mm to + 12mm). Spine fusion extent was a mean 2.1 levels (range 1 – 9) with 15 that included the sacrum/pelvis. Discussion. As surgeons have become aware of the elevated risk of hip dislocation associated with spine fusion/stiffness, several approaches have been proposed to address this risk. Our findings suggest that using the modified direct lateral approach for primary total hip arthroplasty significantly reduces the risk of such a complication. For any tables or figures, please contact the authors directly

Objectives. Understanding lumbar facet joint involvement and biomechanical changes post spinal fusion is limited. This study aimed to establish an in vitro model assessing mechanical effects of fusion on human lumbar facet joints, employing synchronized motion, pressure, and stiffness analysis. Methods and Results. Seven human lumbar spinal units (age 54 to 92, ethics 15/YH/0096) underwent fusion via a partial nucleotomy model mimicking a lateral cage approach with PMMA cement injection. Mechanical testing pre and post-fusion included measuring compressive displacement and load, local motion capture, and pressure mapping at the facet joints. pQCT imaging (82 microns isotropic) was carried out at each stage to assess the integrity of the vertebral endplates and quantify the amount of cement injected. Before fusion, relative facet joint displacement (6.5 ± 4.1 mm) at maximum load (1.1 kN) exceeded crosshead displacement (3.9 ± 1.5 mm), with loads transferred across both facet joints. After fusion, facet displacement (2.0 ± 1.2 mm) reduced compared to pre-fusion, as was the crosshead displacement (2.2 ± 0.6 mm). Post-fusion loads (71.4 ± 73.2 N) transferred were reduced compared to pre-fusion levels (194.5 ± 125.4 N). Analysis of CT images showed no endplate damage post-fusion, whilst the IVD tissue: cement volume ratio did not correlate with the post-fusion behaviour of the specimens. Conclusion. An in vitro model showed significant facet movement reduction with stand-alone interbody cage placement. This technique identifies changes in facet movement post-fusion, potentially contributing to subsequent spinal degeneration, highlighting its utility in biomechanical assessment. Conflicts of interest. None. Sources of funding. This work was funded by EPSRC, under grant EP/W015617/1

The range of allograft products for spinal fusion has been extended with the development of cellular bone matrices (CBMs). Most of these combine demineralized bone with viable cancellous bone prepared in a manner that retains cells with differentiation potential. The purpose of this study was to compare commercially-available human CBMs in the athymic rat model of posterolateral spinal fusion. The products compared were Trinity ELITE® (TEL, OrthoFix), ViviGen (VIV, DePuy Synthes), Cellentra (CEL, Zimmer Biomet), Osteocel® Pro (OCP, NuVasive), Bio4 (BIO, Stryker) and map3 (MAP, RTI Surgical). Bone from the ilia of syngeneic rats was used as a control to approximate the human gold standard. All implants were stored, thawed, and prepared per manufacturer's instructions and all implantations occurred within the manufacturer's time allowance for use after preparation. In total, fifteen 9–10 week old male rats were implanted per implant type, with three different lots of each implant used per five rats to account for lot-to-lot variability. Under anesthesia, a posterior midline longitudinal skin and subcutaneous incision was made, followed by bilateral longitudinal paraspinal myofascial incisions to expose the transverse processes at the L4–5 level. Implants (0.3 cc of allograft or freshly harvested syngeneic iliac bone graft) were placed bilaterally. Surgeons were blinded as to CBM implant type. Incisions were closed with sutures and in vivo microCT scans performed within 48 hours of surgery. A second microCT scan was taken at euthanasia, six weeks after surgery, and the lumbar spines harvested. Fusion was evaluated by manual palpation by three independent, blinded reviewers. MicroCT analysis was performed by an independent CRO (ImageIQ, Cleveland OH). Anonymity of implant type was rigorously kept to avoid bias. By manual palpation, 5/15 (33%) spines of the syngeneic bone group were fused at 6 weeks. The TEL (8/15, 53%) and CEL (11/15, 73%) groups were not significantly different from each other but were from all other CBM groups. Only 2/15 (13%) of VIV-implanted spines fused and none (0/15, 0%) of the OCP, BIO and MAP CBMs produced stable fusion. The mineralized cancellous bone component of the allografts confounded radiographic analysis but microCT analysis indicated bone volume increased over six weeks for all groups except the syngeneic bone (−4.3%). TEL (+65%) and CEL (+73%) were not different from each other but were significantly increased over all other groups (VIV 29%, OCP 37%, BIO 19%, and MAP 45%, respectively). CBMs have distinct formulations and are likely processed differently. The claimed live cell and stem cell contents differ between products. Additionally, map3 has cells added at the time of surgery, whereas the other CBMs are processed to retain matrix-adherent cells. Given the wide range of formulations, differences in performance were not surprising, and Trinity ELITE and Cellentra did significantly better than other implants at both forming new bone and achieving fusion. The other CBMs did not have greater bone formation than the control and were very poor at forming a solid fusion. These findings suggest more careful consideration of these allograft products is needed at the clinical level

Objective

Lumbar spinal stenosis (LSS) is a common spinal disorder mostly caused by the arthritic process. In cases with refractory complaints or significant neurologic deficit, decompressive surgery with or without instrumented fusion may be indicated. We aimed to investigate the surgical outcome of multi-level LSS in the patient with stable spine treated by simple decompression versus decompression and instrumented fusion. Methods: We retrospectively studied 51 patients (25 male, 26 female) with stable multi-level (>2 levels) LSS who were treated by decompressive surgery alone (group A, 31 cases) and decompression and instrumented fusion (group B, 20 cases) and followed them for more than two years. The patients’ disability and pain were assessed with Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS), respectively. At the last follow-up visit, patient satisfaction with surgery was also scored. Results: The two groups were homogeneous in terms of age, sex, severity of disability and pain. Surgery could significantly improve pain and disability in both groups. Preoperative ODI in group A and B were 51.0±23.7 and 54.5±22.9, respectively, however at the last follow-up visit these parameters improved to 23.1±21.1 and 36.6±21.4 showing a statistical significance. Mean patient satisfaction with surgical intervention was also higher in the simple decompression group, but this difference was not significant. Conclusion: In surgical treatment of the patients with multi-level but stable LSS, simple decompression versus decompression and instrumented fusion could achieve more disability improvement for more than two years of follow-up.

Chronic low back pain (CLBP) is the most common cause of disability worldwide, and lumbar spine fusion (LSF) is often chosen to treat pain caused by advanced degenerative disease when clinical treatment failed certain cases, the post-surgical outcomes are not what was expected. Several studies highlight how important are. In psychological variables during the postoperative spine surgery period. The aim of this study is to assess the role of preoperative depression on postoperative clinical outcomes. We included patients who underwent LSF since December 2021. Preoperative depression was assessed administering Beck Depression Inventory questionnaire (BDI). And pain and disability were evaluated at 1, 3, and 6 months, administering respectively Visual Analogic Scale (VAS) and Oswestry Disability Index (ODI). As statistical analysis Mann-Whitney test was performed. We included 46 patients, 20 female (43,5%) and 26 male (56,5%) with an average age of 64,2. The population was divided in two groups, fixing the BDI cut-off point at 10. Patients with BDI < 10 points (N=28) had normal mental health status, instead patients with BDI > 10 points (N=16) had depressive disorders. At 3 months patients with healthy mental status reported statistically significant reduction of pain (U = 372,5, p = .006) and improvement of disability but without statistical significancy (U = 318, p = 0,137). At 6 months patients without psychological disease reported statistically significant reduction of pain (U = 342, p = 0,039) and disability (U = 372,5, p = 0,006). This study demonstrates the correlation between pre-existing depressive state and poorer clinical outcomes after spine surgery. These results are consistent with the literature. Therefore, during the surgical decision making it is crucial to take psychological variables into account in order to predict the results after surgery and inform patients on the potential influence of mental status

Introduction. We have developed a new synthetic hydrogel that can be injected directly into the intervertebral disc (IVD) without major surgery. Designed to improve fixation of joint prosthesis, support bone healing or improve spinal fusion, the liquid may support the differentiation of native IVD cells towards osteoblast-like cells cultured within the hydrogel. Here we investigate the potential of this gel system (Bgel) to induce bone formation within intervertebral disc tissue. Methods. IVD tissue obtained from patients undergoing discectomy, or cadaveric samples, were cultured within a novel explant device. The hydrogel was injected, with and without mesenchymal stem cells (MSCs), and cultured under hypoxia, to mimic the degenerate IVD environment, for 4 weeks. Explants were embedded to wax and native cellular migration into the hydrogel was investigated, together with cellular phenotype and matrix deposition. Results. Increased collagen deposition was seen in tissue explants injected with Bgel, with evidence of elevated native cell migration towards the hydrogel. Increased collagen staining was seen in explants injected with Bgel together with MSCs. Alizarin red staining was utilised to investigate calcium deposition. Tissue explants, in the absence of Bgel, showed limited calcium deposition. This was increased in hydrogel-treated samples, with large clumping regions in the tissue that was injected with Bgel and MSCs. Conclusion. The injection of our synthetic hydrogel into disc tissue explants increased the amount of collagen and calcium deposition. This was further enhanced by the incorporation of MSCs, suggesting the promotion of bone formation. Current work is investigating phenotypic markers for bone formation within these tissues. CS and CLM have a patent on the hydrogel system described in this abstract. Funded by EPSRC and Grow MedTech

The risk of blood transfusion in spinal fusion surgery is significant and mandates efforts to reduce ABT. This prospective study demonstrated a significant reduction in the rate of allogeneic blood transfusion (ABT) using Cell Saver (CS), Preoperative Autologus Donation (PAD), and Preoperative Erythropoietin Therapy (PET). The ABT was inversely related to the number of modalities used: 74% (n=14/19) with zero modalities; 32% (n=24/74) with one modalities; 17% (n=9/52) with two modalities; and 7% (n=2/28) with three modalities. Due to the potential amount of blood loss during spinal fusions the use of several BC techniques in combination is required to effectively reduce ABT. The purpose of this prospective study is to assess the efficacy of current blood conservation (BC) techniques in reducing the rate of allogeneic blood transfusion (ABT) in spinal fusions. All three current blood conservation techniques, particularly in combination, proved to be very effective in reducing the rate of ABT in elective spinal fusions. Transfusion of allogenic blood despite its improved safety is not without risk. From June 1999 to September 2001, transfusion and related surgical data has been prospectively collected in one hundred and seventy-three patients undergoing elective spinal fusions. The following three BC techniques were utilized: Cell Saver (CS), Preoperative Auto-logus Donation (PAD), and Preoperative Erythropoietin Therapy (PET). The average number of fusion levels was 2.3 (range 1–5). The average estimated blood loss was 1725 milliliters (range 250–10700). Decompression was also preformed in 75% of cases. The overall ABT rate was 28% (n=49/173). The ABT was inversely related to the number of modalities used: 74% (n=14/19) with zero modalities; 32%* (n=24/74) with one modalities; 17%* (n=9/52) with two modalities; and 7%*† (n=2/28) with three modalities respectively (*statistically significant compared to zero modality group; † statistically significant compared to one modality group). The patient demographics and surgical variables were similar between the four groups. The use of CS, PAD, and PET was independently related to ABT. The risk of blood transfusion in spinal fusion surgery is significant and mandates efforts to reduce ABT. Due to the amount of blood loss the use of several BC techniques in combination is required to effectively reduce ABT

This study aims to explore the trend in spine fusion surgery in Australia over the past 10 years and to explore the possible influence of health insurance status (private versus public) on the rate of surgery. Data pertaining to the rate of lumbar spine fusion from 1997 to 2006 were collected. Data on publicly performed procedures in NSW were obtained from Inpatient Statistics Collection of NSW Health, and data on privately performed procedures were obtained from Medicare Australia Statistics. Population data was obtained from the Australian Bureau of Statistics. Data on total hip and total knee arthroplasties performed were collected to provide a comparator. Health insurance coverage was also investigated to control for insurance status, this data was obtained from the Private Health Insurance Administration Council. There has been a slowly declining trend in the number of publicly performed spinal fusion procedures over the past 10 years, falling by 63% from 1997 to 2006 in NSW. In comparison, privately performed spinal fusion procedures have increased by 166% over the same 10 year period. Compared to spine fusion, the rates of total hip and total knee replacement procedures in the public sector of NSW have fallen by smaller proportions (58.9%% and 42.1%, respectively) over the same 10 year period. The increase in privately performed joint replacements has been less than that seen for spine fusion, with increases of 120% and 74%% for knee arthroplasties and hip arthroplasties, respectively. In 2006, spine fusion surgery was 10.8 times more likely to be done in the private sector than in the public sector, compared to corresponding figures of 4.2 times and 3.0 times for knee replacement and hip replacement, respectively. Our study has demonstrated that there is a disproportionately high rate of spine fusion procedures performed in the private sector. Possible explanations for this difference include: over servicing in the private sector, under servicing in the public sector, differences in medical referral patterns, surgeon and patient preferences, and financial incentives

A literature review of bone graft substitutes for spinal fusion was undertaken from peer reviewed journals to form a basis for guidelines on their clinical use. A PubMed search of peer reviewed journals between Jan 1960 and Dec 2009 for clinical trials of bone graft substitutes in spinal fusion was performed. Emphasis was placed on RCTs. Small and duplicated RCTs were excluded. If no RCTs were available the next best clinical evidence was assessed. Data were extracted for fusion rates and complications. Of 929 potential spinal fusion studies, 7 RCTs met the inclusion criteria for BMP-2, 3 for BMP-7, 2 for Tricalcium Phosphate and 1 for Tricalcium Phosphate/Hydroxyapatite (TCP/HA). No clinical RCTs were found for Demineralised Bone Matrix (DBM), Calcium Sulphate or Calcium Silicate. There is strong evidence that BMP-2 with TCP/HA achieves similar or higher spinal fusion rates than autograft alone. BMP-7 achieved similar results to autograft. 3 RCTs support the use of TCP or TCP/HA and autograft as a graft extender with similar results to autograft alone. The best clinical evidence to support the use of DBMs are case control studies. The osteoinductive potential of DBM appears to be very low however. There are no clinical studies to support the use of Calcium Silicate. The current literature supports the use of BMP-2 with HA/TCP as a graft substitute. TCP or HA/TCP with Autograft is supported as a graft extender. There is not enough clinical evidence to support other bone graft substitutes. This study did not require ethics approval and no financial support was received

Purpose: A significant proportion of spine fusion operations may result in a non-union. Electromagnetic stimulation is a non-invasive method used to promote spine fusion although the efficacy of its use in this regard remains uncertain. The purpose of this systematic review and meta-analysis is to evaluate the effect of electromagnetic stimulation on spine fusion. Method: Five electronic databases (MEDLINE, Embase, CINAHL, PubMed and the Cochrane Central Register of Controlled Trials) were searched from database inception to July 2009 for randomized controlled trials of electrical stimulation and spinal fusion. In addition, we performed a hand search of four relevant journals from January 2000 to July 2009, the on-line proceedings of the North American Spine Society Annual Meeting from 2002 to 2008 and bibliographies of eligible trials. Trials randomizing adult patients undergoing any type of spine fusion to active treatment with direct current, capacitance coupled or pulsed electromagnetic field stimulation or placebo and reporting on fusion rates were included. Two independent reviewers extracted data regarding clinical outcomes, stimulation device, treatment regimen and methodologic quality. Results: Of 1650 studies identified seven met the inclusion criteria. Electromagnetic stimulation in lumbar spine fusion was evaluated in five studies and two addressed cervical spine fusions. The use of electromagnetic stimulation in lumbar spine fusion resulted in a significant decrease in the risk of non-union (relative risk 0.60, 95% confidence interval 0.38 to 0.93, p = 0.02, I2 = 57%). The observed reduction in risk of nonunion with electromagnetic stimulation was not affected by smoking or the number of levels fused. Due to limited and conflicting trials, similar effects were not observed in the two studies evaluating cervical spine fusion rates (relative risk 0.85, 95% confidence interval 0.29 to 2.53, p = 0.77, I2 = 56%). Conclusion: Pooled analysis shows a 40% reduction in the risk of non-union of lumbar spine fusions with the use of electromagnetic stimulation although a similar effect was not observed for fusions of the cervical spine. However, due to study heterogeneity the current indications for the use of electrical stimulation in spine fusion remain somewhat unclear

Posterior spinal surgery is associated with a significant amount of blood loss. The factors predisposing the patient to excessive bleeding-and therefore transfusion- are not well established nor is the effect of transfusion on the outcomes following spinal surgery. We had two goals in this study. First, we were to investigate any suspected risk factors of transfusion in posterior thoraco-lumbar fusion patients. Second, we wanted to observe the negative impact-if one existed- of transfusion on the outcomes of surgery. All adults undergoing posterior thoraco-lumbar spine fusion in our institution from May 2015 to May 2018 were included. Data collected included demographic data as well as BMI, preoperative hemoglobin, American Society of Anesthesiologists classification (ASA), delta Hemoglobin, estimated blood loss, incidence of transfusion, number of units transfused, number of levels fused, length of stay and re-admission within 30 days. The data was analyzed to correlate these variables with the frequency of transfusion and then to assess the association of adverse outcomes with transfusion. 125 patients were included in the study. Only 6 patients (4.8%) required re-admission within the first 30 days after discharge. Length of stay averaged 8.4 days (3–74). 18 patients (14.4%) required transfusion peri-operatively. When multiple variables were analyzed for any correlation, the number of levels fused, age and BMI had statistically significant correlation with the need for transfusion (P <0.005). Patients undergoing posterior thoraco-lumbar fusion are more likely to require blood transfusion if they were older, over-weight & obese or had a multi-level fusion. Receiving blood transfusion is associated with increased complication rates

The functional pelvic tilt when standing and sitting forward of 7402 cases on the OPS, Optimized Ortho, Australia Data Base were reviewed. All patients had undergone lateral radiographs when standing simulating extension of the hip, and sitting forward when the hip is near full flexion. Pelvic tilt was measured as the angle of the Anterior Pelvic Plane to the vertical Sagittal Plane, rotation anteriorly being given a positive value. Pelvises that had rotated more than 13 degrees anteriorly (+ve) when sitting forward or posteriorly (-ve) when standing were considered to place the hip at increased risk of dislocation or edge loading when flexed or extending respectively. This degree of rotation has the effect of changing the acetabular version by approximately10. 0. Most safe zones that have been described have given a range of anteversion of 20. 0. as safe. A change of 10. 0. would potentially place the acetabular orientation outside this range. Further, clinical studies have supported this concept. All lateral radiographs were reviewed to confirm that 281 had undergone instrumented spinal fusion at some level between T12 and S1. There was a large variability in the number and the levels arthrodesed. The range of pelvic mobility in the non-arthrodesed group in extension was −37. 0. to 31. 0. (mean −0.9. 0. , Standard deviation 7.49) and in flexed position was −70. 0. to 49. 0. (mean −1.9. 0. , Standard deviation 14.01). For the group with any fusion the range of pelvic tilt in extension was −31. 0. to 22. 0. (mean −4. 0. , Standard deviation 8.21) and flexed −32. 0. to 46. 0. (mean 4.4. 0. , Standard deviation 13.79). Of the 7121 cases without instrumented fusion, 15.5% were considered to be at risk when in flexion and 6.1% when extended. The risk for those with any fusion was approximately doubled in both flexion and extension. Further, those with extensive arthrodesis from T12 to S1 had a range of pelvic tilts similar to the non-fused group, although they had a significantly higher percentage of cases in the ‘at risk’ zones. The proportion of the cases in the ‘at risk’ zones decreased progressively as the arthrodesed levels moved from L5/S1 to the upper lumbar spine, and with decreasing number of levels fused. Conclusion. Spinal fusion is not just one group as there are many combinations of different levels fused. Patients with instrumented spinal fusions do have a proportionately high risk of failure of their THR than the majority of cases with no instrumentation, though the risk varies significantly with the number of levels and actual levels arthrodesed. Further approximately 21% of cases with no spinal fusion have functional pelvic movements that would potentially place them ‘at risk’ of edge loading or dislocation. For any figures or tables, please contact authors directly