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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 4 - 4
2 Jan 2024
Kucko N Sage K Delawi D Hoebink E Kempen D Van Susante J de Bruijn J Kruyt M
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Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 11 - 11
2 Jan 2024
Petrucci G Papalia GF Russo F Ambrosio L Papalia R Vadalà G Denaro V
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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


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 9 - 9
2 Jan 2024
Vadalà G Papalia G Russo F Ambrosio L Franco D Brigato P Papalia R Denaro V
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The use of intraoperative navigation and robotic surgery for minimally invasive lumbar fusion has been increasing over the past decade. The aim of this study is to evaluate postoperative clinical outcomes, intraoperative parameters, and accuracy of pedicle screw insertion guided by intraoperative navigation in patients undergoing lumbar interbody fusion for spondylolisthesis. Patients who underwent posterior lumbar fusion interbody using intraoperative 3D navigation since December 2021 were included. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and Short Form Health Survey-36 (SF-36) were assessed preoperatively and postoperatively at 1, 3, and 6 months. Screw placement accuracy, measured by Gertzbein and Robbins classification, and facet joint infringement, measured by Yson classification, were assessed by intraoperative Cone Beam CT scans performed at the end of instrumentation. Finally, operation time, intraoperative blood loss, hospital stay, and screw insertion time were evaluated. This study involved 50 patients with a mean age of 63.7 years. VAS decreased from 65.8±23 to 20±22 (p<.01). ODI decreased from 35.4%±15 to 11.8%±14 (p<.01). An increase of SF-36 from 51.5±14 to 76±13 (p<.01) was demonstrated. The accuracy of “perfect” and “clinically acceptable” pedicle screw fixation was 89.5% and 98.4%, respectively. Regarding facet violation, 96.8% of the screws were at grade 0. Finally, the average screw insertion time was 4.3±2 min, hospital stay was 4.2±0.8 days, operation time was 205±53 min, and blood loss was 169±107 ml. Finally, a statistically significant correlation of operation time with hospital stay, blood loss and placement time per screw was found. We demonstrated excellent results for accuracy of pedicle screw fixation and violation of facet joints. VAS, ODI and SF-36 showed statistically significant improvements from the control at one month after surgery. Navigation with intraoperative 3D images represents an effective system to improve operative performance in the surgical treatment of spondylolisthesis


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 31 - 31
1 Dec 2022
Ambrosio L Vadalà G Russo F Donnici L Di Tecco C Iavicoli S Papalia R Denaro V
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With the coronavirus disease 2019 (COVID-19) pandemic, remote working has been ubiquitously implemented to reduce disease transmission via minimization of in-person interactions. Low back pain (LBP) is the first cause of disability worldwide and is frequently reported by workers with sedentary occupations. This cross-sectional study aimed to assess the role of remote working in a population of adults affected by LBP through an online questionnaire. We enrolled 136 teleworkers affected by LBP. A total of 101 responses were received and 93 suitable questionnaires were included in the final analysis. Demographic data, remote working features and tasks, and LBP burden were analysed. The psychological burden of remote working was evaluated with the World Health Organization Five Well-Being Index (WHO-5) and the Patient Health Questionnaire-2 (PHQ-2). LBP severity was evaluated using a visual analog scale (VAS). LBP-related disability was assessed using the Oswestry Disability Index (ODI). The effect of LBP on working capacity was examined with the Occupational Role Questionnaire (ORQ). Independent risk factors related to LBP worsening were identified using a multivariate logistic regression model. LBP severity was significantly higher compared to previous in-person working (p<0.0001) as well as average weekly work hours (p<0.001). Furthermore, the risk of LBP deterioration was associated with being divorced (OR: 4.28, 95% CI: 1.27-14.47; p=0.019) or living with others (OR: 0.24, 95% CI: 0.07-0.81; p=0.021), higher ill-being (OR: 0.91, 95% CI: 0.83-0.99; p=0.035) and depression scores (OR: 1.38, 95% CI: 1.00-1.91; p=0.048), as well as having reported unchanged (OR: 0.22, 95% CI: 0.08-0.65; p=0.006) or decreased job satisfaction (OR: 0.16, 95% CI: 0.05-0.54; p=0.003) and increased stress levels (OR: 3.00, 95% CI: 1.04-8.65; p=0.042). These findings highlight key factors to consider for improving remote workers’ physical and mental wellbeing and decrease their LBP burden


Abstract. Objectives. The principle of osteoporotic vertebral compression fracture (OVCF) is fixing instability, providing anterior support, and decompression. Contraindication for vertebroplasty is anterior or posterior wall fracture. The study objectives was to evaluate the efficacy and safety of vertebroplasty with short segmented PMMA cement augmented pedicle screws for OVCF with posterior/anterior wall fracture patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ±0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20±5.90 to 5.30±1.40 postoperative with 5% (3.30± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80±11.9% t0 87.6±13.1% postoperative with 4.5±4.0% loss at final follow-up. One case had cement leakage was found, but the patient is asymptomatic. No implant-related complication was seen. No iatrogenic dural or nerve injury. Conclusions. Treatment with vertebroplasty with cement augmented screw fixation and direct decompression is a great option in treating such a complex situation in fragile age with fragile bones because It provides anterior support with cementing that avoids corpectomy. Short segment fixation has less stress risers at the junctional area


Abstract. Objectives. To evaluate the safety and efficacy of vertebroplasty with short segmented cement augmented pedicle screws fixation for severe osteoporotic vertebral compression fractures (OVCF) with posterior/anterior wall fractured patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ± 0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20 ± 5.90 to 5.30 ± 1.40 postoperative with 5% (3.30 ± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80 ± 11.9% to 87.6 ± 13.1% postoperative with 4.5 ± 4.0% loss at final follow-up. One case had cement leakage was found, but the patient is asymptomatic. No implant-related complication was seen. No iatrogenic dural or nerve injury. Conclusions. Treatment with vertebroplasty with cement augmented screw fixation and direct decompression is a great option in treating such a complex situation in fragile age with fragile bones because. Vertebroplasty is viable option for restoring vertebral anterior column in patients who are considered as contraindications for vertebroplasty, like DGOU-4. It provides anterior support avoiding corpectomy, minimise blood loss and also duration of surgery. Addition of short segment fixation gives adequate support with less stress risers at the junctional area


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 107 - 107
1 Dec 2020
Omidi-Kashani F Binava R Arki ZM Keshtan FG Madarshahian D
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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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XI | Pages 23 - 23
1 Apr 2012
Higgs Z Brownson N Ford A Verghese G
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Lumbar Spinal Canal Stenosis is a common condition in the ageing population. In Spinal decompression surgery a balance needs to be struck between the need to decompress the neural elements in the spinal canal and the risk of worsening the segmental instability that often coexists in this condition. Traditionally decompression has been supplemented with rigid stabilization e.g. fusion, which is irreversible. Recently semi-rigid or ‘soft’ stabilization philosophies have evolved. The Wallis Device is a second generation interspinous distraction/stabilization implant designed to achieve ‘soft’ segmental stabilization. In addition to stabilising the decompressed segment, it also provides a ‘block’ to full segmental extension, helping to maintain spinal canal dimensions even in the erect position. We followed up and assessed outcomes in 50 patients (25 spinal decompression + Wallis implant and 25 spinal decompression alone). The two arms of the study were matched for gender, age and level of lumbar decompression. A single surgeon was involved in each case and carried out a standard procedure of fenestration and medial facetectomy. Outcomes were assessed during clinical follow-up as well as by telephone, and included the VAS, the Oswestry Disability Index (ODI) and the EQ5D Health Domain. Early results suggest decreased incidence of recurrent symptoms and global improvement in all parameters measured, in those subjects that underwent Spinal decompression with Wallis stabilisation


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 27 - 27
1 Jan 2013
Staiger C Giannetti B Tschaikin M
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The objective of this trial was to investigate the efficacy of a Comfrey root extract cream in patients with acute upper or lower back pain. The study was conducted as a double-blind, multi-centre, parallel group design RCT over a period of 5 ± 1 days. The patients (n=120, mean age 36.9 years, 46.7 % female) were treated three times a day, 4 g cream per application. The trial included four visits. The primary efficacy variable was the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at visits 1 to 4. Among the secondary objectives were back pain at rest (VAS), pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and investigator, and functional impairment measured with the Oswestry Disability Index. There was a significant treatment difference between verum and placebo. In the course of the trial the primary variable decreased on average (median) about 95,2 % in the Comfrey extract group and 37.8 % in the placebo group. The results separated by pain location show an equivalent effect of comfrey extract: Regarding pain at rest, in lower back pain a reduction of 98% were observed, in upper back pain 96.9%. The results of this RCT were clear-cut and consistent across all variables. Comfrey root extract cream showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 hour) was also witnessed in this trial. Conflicts of interest and sources of funding. CS and MT are employees of Merck Selbstmedikation GmbH, the sponsor of the presented clinical trial. BMG is CEO of CRM Pharmaberatung GmbH, the CRO of the presented clinical trial


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 25 - 25
1 Jan 2013
McGregor A Doré C Morris T Morris S Jamrozik K
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Introduction. This study sought to determine whether the functional outcome of two common spinal operations could be improved by a programme of post-operative rehabilitation and/or an educational booklet each compared with usual care. Methods. This was a multi-centre, factorial, randomised controlled trial on the post operative management of spinal surgery patients, with randomisation stratified by surgeon and operative procedure. The study compared the effectiveness of a rehabilitation programme and an education booklet for the postoperative management of patients undergoing discectomy or lateral nerve root decompression surgery, each compared with “usual care” using a 2 × 2 factorial design, randomising patient to four groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care only. The primary outcome measure was the Oswestry Disability Index (ODI) at 12 months, with secondary outcomes including visual analogue scale measures of back and leg pain. An economic analysis was also performed. Results. 338 patients were recruited into the study with outcomes preformed pre-operatively, and postoperatively at 6 weeks, 3, 6, 9 and 12 months post-operatively. At the one year review the effect of rehabilitation on ODI was −2.7 (95% CI −6.8 to 1.5) and the effect of booklet was 2.7 (95% CI −1.5 to 6.9). There were no significant differences in costs or outcomes associated with either intervention and neither intervention was cost-effective. Discussion. This study found that neither intervention had a significant impact on long term outcome or cost. There was some evidence to suggest that the impact of the interventions was different between patients undergoing discectomy and those having spinal decompression. Conflicts of Interest. None. Source of Funding. Arthritis Research UK. Previously presented at International Society for the Study of the Lumbar Spine 2011


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XI | Pages 1 - 1
1 Apr 2012
Augustine A Horey L Murray H Craig D Meek R Patil S
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The diagnosis and treatment of hip disease in young adults has rapidly evolved over the past ten years. Despite the advancements of improved diagnostic skills and refinement of surgical techniques, the psychosocial impact hip disease has on the young adult has not yet been elucidated. This observational study aimed to characterise the functional and psychosocial characteristics of a group of patients from our young hip clinic. 49 patients responded to a postal questionnaire which included the Oswestry Disability Index (ODI) and Hospital Anxiety and Depression Scale (HADS). Median age was 20 years (range 16-38) with a gender ratio of 2:1 (female: male). The most common diagnoses were Perthes' disease and developmental hip dysplasia. More than half of our patients had moderate to severe pain based on the Visual Analogue Scale (VAS) and at least a moderate disability based on the ODI. Thirty-two percent of patients were classified as having borderline to abnormal levels of depression and 49% of patients were classified as having borderline to abnormal levels of anxiety based on the HADS. Comparison of the ODI with the VAS and HADS anxiety and depression subscales showed a significant positive correlation (p<0.05). Multiple regression showed the ODI to be a significant predictor of the HADS anxiety and depression scores (regression coefficient 0.13, 95% confidence interval 0.06 to 0.21, p<0.05). This study highlights the previously unrecognised psychosocial effects of hip disease in the young adult. A questionnaire which includes HADS may be of particular value in screening for depression and anxiety in young people with physical illness. This study also highlights that collaboration with psychologists and other health care providers may be required to achieve a multidisciplinary approach in managing these patients