Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data. DESIGN: Economic evaluation alongside a randomized controlled trial with two-year follow-up. SETTING: Patients from the outpatient clinics of a university hospital and a general hospital. SUBJECTS: A total of 82 lumbar spinal fusion patients. INTERVENTIONS: Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation. MAIN MEASURES: Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects. RESULTS: No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion. CONCLUSION: This case manager-assisted rehabilitation programme was unlikely to be cost-effective.

Does adding case management to standard rehabilitation affect functional ability, pain, or the rate of return to work after lumbar spinal fusion? A randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the effect of a case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation in patients undergoing lumbar spinal fusion. DESIGN: A randomized controlled trial with a two-year follow-up. SETTINGS: Outpatient clinics of a university hospital and a general hospital. SUBJECTS: In total, 82 patients undergoing lumbar spinal fusion. INTERVENTIONS: The patients were randomized one-to-one to case manager-assisted rehabilitation (case manager group) or no case manager-assisted rehabilitation (control group). Both groups received usual physical rehabilitation. The case manager-assisted rehabilitation programme included a preoperative meeting with a case manager to determine a rehabilitation plan, postsurgical meetings, phone meetings, and voluntary workplace visits or roundtable meetings. MAIN MEASURES: Primary outcome was the Oswestry Disability Index. Secondary outcomes were back pain, leg pain, and return to work. RESULTS: Of the 41 patients in the case manager group, 49% were men, with the mean age of 46.1 (±8.7 years). In the control group, 51% were male, with the mean age of 47.4 (±8.9 years). No statistically significant between-group differences were found regarding any outcomes. An overall group effect of 4.1 points (95% confidence interval (CI): -1.8; 9.9) was found on the Oswestry Disability Index, favouring the control group. After two years, the relative risk of return to work was 1.18 (95% CI: 0.8; 1.7), favouring the case manager group. CONCLUSION: The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation. The study lacked power to evaluate the impact on return to work.

How good are the outcomes of instrumented debulking operations for symptomatic spinal metastases and how long do they stand? A subgroup analysis in the global spine tumor study group database.

BACKGROUND: The benefits of surgery for symptomatic spinal metastases have been demonstrated, largely based on series of patients undergoing debulking and instrumentation operations. However, as cancer treatments improve and overall survival lengths increase, the incidence of recurrent spinal cord compression after debulking may increase. The aim of the current paper is to document the postoperative evolution of neurological function, pain, and quality of life following debulking and instrumentation in the Global Spine Tumor Study Group (GSTSG) database. METHODS: The GSTSG database is a prospective multicenter data repository of consecutive patients that underwent surgery for a symptomatic spinal metastasis. For the present analysis, patients were selected from the database that underwent decompressive debulking surgery with instrumentation. Preoperative tumor type, Tomita and Tokuhashi scores, EQ-5D, Frankel, Karnofsky, and postoperative complications, survival, EQ-5D, Frankel, Karnofsky, and pain numeric rating scores (NRS) at 3, 6, 12, and 24 months were analyzed. RESULTS: A total of 914 patients underwent decompressive debulking surgery with instrumentation and had documented follow-up until death or until 2 years post surgery. Median preoperative Karnofsky performance index was 70. A total of 656 patients (71.8%) had visceral metastases and 490 (53.6%) had extraspinal bone metastases. Tomita scores were evenly distributed above (49.1%) and below or equal to 5 (50.9%), and Tokuhashi scores almost evenly distributed below or equal to 8 (46.3%) and above 8 (53.7%). Overall, 12-month survival after surgery was 56.3%. The surgery resulted in EQ-5D health status improvement and NRS pain reduction that was maintained throughout follow-up. Frankel scores improved at first follow-up in 25.0% of patients, but by 12 months neurological deterioration was observed in 18.8%. CONCLUSION: We found that palliative debulking and instrumentation surgeries were performed throughout all Tomita and Tokuhashi categories. These surgeries reduced pain scores and improved quality of life up to 2 years after surgery. After initial improvement, a proportion of patients experienced neurological deterioration by 1 year, but the majority of patients remained stable.

New growth rod concept provides three dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis.

INTRODUCTION: This study aims to describe a novel minimal invasive early-onset scoliosis (EOS) growth rod concept, the Cody Bünger (CB) Concept, which combines concave interval distraction and contralateral-guided growth with apical control and to investigate the 3D deformity correction, the spinal growth, and the pulmonary development. METHOD: A series of 38 children with progressive EOS and growth potential, receiving a highly specialized surgical treatment, including primary and conversion cases. Mean age was 10.2 years (4.4-15.8) with a mean follow-up of 5.6 years, and they underwent 168/184 open/magnetic lengthening procedures. Outcomes were as follows: scoliosis, kyphosis, and lordosis angles; apical rotation; spinal length; apical translation; coronal and sagittal vertical alignment; complications; and pulmonary function in a subgroup. RESULTS: Scoliosis improved from mean 76° (46-129) to 35° (8-74) post-op and was 42° (13-83) at end of treatment. Apical rotation was reduced by 30% but was partially lost during treatment. Thoracic kyphosis initially decreased by mean 15° and was partially lost during treatment. Lordosis was largely unaltered during treatment. Mean T1-S1 height increased from 30.7 cm (22.7-39.2) to 34.6 cm (27.8-45.1) postop and further increased to 38.5 cm (30.1-48.1) during treatment. This corresponded to a T1-S1 growth rate of 12 mm/year, and positive growth rates were found in all height parameters evaluated. Frontal balance and apical translation improved, whereas sagittal balance was unaltered. Complications occurred in 22/38 patients, and 11/38 had an unintended reoperation. Pulmonary function (FVC and FEV) increased but the relative lung function was unchanged. CONCLUSION: The new growth rod concept provided 3D correction and spinal growth at complication rates comparable with other growth-friendly techniques for EOS, while pulmonary function was preserved. Single magnetic rod distraction was incorporated successfully, replacing surgical elongations.

Health-care costs of conservative management of spine fractures in trauma patients.

BACKGROUND AND PURPOSE: There is a lack of evidence on the broad health-care costs of treating spine trauma patients without neurological deficits conservatively. The aim of the present study was to estimate the primary and secondary health-care sector costs associated with conservative treatment of spine fractures as well as their determinants. METHODS: Patients were identified between 1999 and 2008 in the hospital's administrative system based on relevant diagnostic codes. Inclusion criteria were: (1) spine fractures (C1-L5); (2) age >18; and (3) conservative treatment. Exclusion criteria were: (1) neurological involvement and (2) fractures secondary to osteoporosis/malignancy. Health-care utilization and costs were retrieved from national administrative databases covering the entire health-care sector. RESULTS: 201 cervical, 150 thoracic, and 140 lumbar fracture patients were included in the study. The total health cost was estimated at €18,919 (16,199; 21,756), €8571 (6062; 11,733), €5526 (3473; 7465) for cervical, thoracic, and lumbar regions, respectively. Hospital admissions accounted for the vast majority of costs while primary health care accounted for less than 3 % and prescription medication for less than 2 %. The determinants of costs included fracture site (p < 0.001) and concomitant lower limb injuries (p = 0.009). CONCLUSIONS: Spinal fractures, even mild ones, appear to incur substantial health-care utilization and costs. Health-care costs in conjunction with cervical fractures are more than two-fold of those affiliated with thoracic and lumbar fractures. Among the concomitant injuries, lower limb injuries exert a substantial influence over health-care costs.

Addition of TLIF does not improve outcome over standard posterior instrumented fusion. 5-10 years long-term Follow-up: results from a RCT.

PURPOSE: The use of inter-body device in lumbar fusions has been difficult to validate, only few long-term RCT are available. METHODS: Between 2003 and 2005, 100 patients entered a RCT between transforaminal lumbar inter-body fusion (TLIF) or posterolateral instrumented lumbar fusion (PLF). The patients suffered from LBP due to segmental instability, disc degeneration, former disc herniation, spondylolisthesis Meyerding grade <2. Functional outcome parameters as Dallas pain questionnaire (DPQ), SF-36, low back pain questionnaire (LBRS), Oswestry disability index (ODI) were registered prospectively, and after 5-10 years. RESULTS: Follow-up reached 93 % of available, (94 %, 44 in the PLF's and 92 %, 44 in the TLIF group p = 0.76). Mean follow-up was 8.6 years (5-10 years). Mean age at follow-up was 59 years (34-76 years p = 0.19). Reoperation rate in a long-term perspective was equal among groups 14 %, each p = 0.24. Back pain was 3.8 (mean) (Scale 0-10), TLIF (3.65) PLF (3.97) p = 0.62, leg pain 2.68 (mean) (Scale 0-10) 2.90 (TLIF) and 2.48 (PLF) p = 0.34. No difference in functional outcome between groups p = 0.93. Overall, global satisfaction with the primary intervention at 8.6 year was 76 % (75 % TLIF and 77 % PLF) p = 0.85. CONCLUSION: In a long-term perspective, patients with TLIF's did not experience better outcome scores.

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients.

BACKGROUND: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF). METHODS: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records. RESULTS: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention. CONCLUSION: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention. TRIAL REGISTRATION: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

Rapid improvements in pain and quality of life are sustained after surgery for spinal metastases in a large prospective cohort.

Introduction Metastatic spinal cancer is a common condition that may lead to spinal instability, pain and paralysis. In the 1980s, surgery was discouraged because results showed worse neurological outcomes and pain compared with radiotherapy alone. However, with the advent of modern imaging and spinal stabilisation techniques, the role of surgery has regained centre stage, though few studies have assessed quality of life and functional outcomes after surgery. Objective We investigated whether surgery provides sustained improvement in quality of life and pain relief for patients with symptomatic spinal metastases by analysing the largest reported surgical series of patients with epidural spinal metastases. Methods A prospective cohort study of 922 consecutive patients with spinal metastases who underwent surgery, from the Global Spine Tumour Study Group database. Pre- and post-operative EQ-5D quality of life, visual analogue pain score, Karnofsky physical functioning score, complication rates and survival were recorded. Results Quality of life (EQ-5D), VAS pain score and Karnofsky physical functioning score improved rapidly after surgery and these improvements were sustained in those patients who survived up to 2 years after surgery. In specialised spine centres, the technical intra-operative complication rate of surgery was low, however almost a quarter of patients experienced post-operative systemic adverse events. Conclusion Surgical treatment for spinal metastases produces rapid pain relief, maintains ambulation and improves good quality of life. However, as a group, patients with cancer are vulnerable to post-operative systemic complications, hence the importance of appropriate patient selection.

Aarhus Regenerative Orthopaedics Symposium (AROS).

The combination of modern interventional and preventive medicine has led to an epidemic of ageing. While this phenomenon is a positive consequence of an improved lifestyle and achievements in a society, the longer life expectancy is often accompanied by decline in quality of life due to musculoskeletal pain and disability. The Aarhus Regenerative Orthopaedics Symposium (AROS) 2015 was motivated by the need to address regenerative challenges in an ageing population by engaging clinicians, basic scientists, and engineers. In this position paper, we review our contemporary understanding of societal, patient-related, and basic science-related challenges in order to provide a reasoned roadmap for the future to deal with this compelling and urgent healthcare problem.

Healthcare costs attributable to the treatment of patients with spinal metastases: a cohort study with up to 8 years follow-up.

BACKGROUND: Cancer treatment, and in particular end-of-life treatment, is associated with substantial healthcare costs. The purpose of this study was to analyse healthcare costs attributable to the treatment of patients with spinal metastases. METHODS: The study population (n = 629) was identified from clinical databases in Denmark. Patients undergoing spinal metastasis treatment from January 2005 through June 2012 were included. Clinical data were merged with national register data on healthcare resource use, costs and death date. The analytic period ranged from treatment initiation until death or administrative censoring in October 2013. Analysis of both survival and costs were stratified into four treatment regimens of increasing invasiveness: radiotherapy (T1), decompression (T2), decompression + instrumentation (T3) and decompression + instrumentation + reconstruction (T4). Survival was analysed using Kaplan-Meier curves. Costs were estimated from a healthcare perspective. Lifetime costs were defined as accumulated costs from treatment initiation until death. The Kaplan-Meier Sampling Average method was used to estimate these costs; 95% CIs were estimated using nonparametric bootstrapping. RESULTS: Mean age of the study population was 65.2 years (range: 19-95). During a mean follow-up period of 9.2 months (range: 0.1-94.5 months), post treatment survival ranged from 4.4 months (95% CI 2.5-7.5) in the T1 group to 8.7 months (95% CI 6.7-14.1) in the T4 group. Inpatient hospitalisation accounted for 65% and outpatient services for 31% of the healthcare costs followed by hospice placements 3% and primary care 1%. Lifetime healthcare costs accounted for €36,616 (95% CI 33,835-39,583) per T1 patients, €49,632 (95% CI 42,287-57,767) per T2 patient, €70997 (95% CI 62,244-82,354) per T3 patient and €87,814 (95% CI 76,638-101,528) per T4 patient. Overall, 45% of costs were utilised within the first month. T1 and T4 patients had almost identical distributions of costs: inpatient hospitalisation averaged 59% and 36% for outpatient services. Costs of T2 and T3 were very similarly distributed with an average of 71% for inpatient hospitalisation and 25% for outpatient services. CONCLUSION: The index treatment accounts for almost half of lifetime health care costs from treatment initiation until death. As expected, lifetime healthcare costs are positively association with invasiveness of treatment.

Intervertebral disc degenerative changes after intradiscal injection of TNF-α in a porcine model.

PURPOSE: To investigate whether exogenous tumor necrosis factor-α (TNF-α) will initiate a degenerative process in intervertebral disc in vivo. METHODS: Exogenous TNF-α in dosages of 50 and 100 ng in 50 µL Dulbecco's Modified Essential Medium (DMEM) was injected into porcine lumbar discs; a third disc was injected only with 50 µL DMEM as a control. Magnetic resonance imaging (MRI) yielding T1- and T2-weighted images, T2-mapping, and post-contrast T1 images was performed and histology was studied as well. RESULTS: After 3 months, a significant decrease in T2 value calculated from T2-mapping MRI was observed in the annulus and nucleus of both groups injected with TNF-α along with a slight decrease in disc height and nucleus volumes in comparison to the control discs. No obvious visual differences among the groups were observed in the normal T1- and T2-weighted MRI images. Post-contrast T1 MRI showed increased annulus enhancement in both TNF-α-injected groups compared to the control discs, while no enhancement difference was observed in the nucleus. Histological analysis showed degenerative changes with annulus fissure, cell cluster, nucleus matrix loss, vascularization and interleukin-1ß expression in the outer annulus of both TNF-α-injected discs, while no degenerative changes were observed in the control discs. CONCLUSIONS: Intradiscal injection of exogenous TNF-α caused early stage disc degeneration in a porcine model. It may thus support the hypothesis of exogenic TNF-α being an important early pathogenetic factor in disc degeneration.

Do postoperative radiographically verified technical success, improved cosmesis, and trunk shift corroborate with patient-reported outcomes in Lenke 1C adolescent idiopathic scoliosis?

PURPOSE: To examine correlation between postoperative radiographic and cosmetic improvements in Lenke 1C adolescent idiopathic scoliosis (AIS) with patients' self-rated outcomes of health and disability at follow-up as determined by the Scoliosis Research Society questionnaire (SRS-30), Oswestry Disability Index score (ODI) and measure of overall health quality Euroqol-5d (EQ-5D). METHODS: 24 Lenke 1C scoliosis patients, mean age 16.5 (12.8-38.1) years, treated with posterior pedicle screw-only construct, were included. The coronal profile indices (radiographic and cosmetic) regarding magnitude of spinal deformity and truncal balance were measured preoperatively, postoperatively and at final follow-up. A comprehensive index of overall back symmetry was also measured by means of the Posterior Trunk Symmetry Index (POTSI). Pearson's correlation analysis determined the association between the radiographic-cosmetic indices and patient-rated outcomes. RESULTS: Mean follow-up for the cohort was 4.4 (±1.86) years. The thoracic apical vertebra-first thoracic vertebra horizontal distance (AV-TI) correction had significant correlation with function, self-image, and mental health SRS-30 scores (0.55, 0.54, 0.66). Similarly, thoracic apical vertebra horizontal translation from central sacral vertical line (AV-CSVL) correction at follow-up had significant correlation with self-image and management domains (0.57, 0.50). Follow-up POTSI correlated well with SRS-30 and EQ-5D scores (r = -0.64, -0.54). Postoperative leftward trunk shift/spinal imbalance did not influence overall cosmesis and outcomes; significant spinal realignment was evident in follow-up resulting in physiological balance and acceptable cosmesis and outcomes. CONCLUSION: Significant, but less than "perfect" correlations were observed between the radiographic, cosmetic measures and patient-rated outcomes. Thoracic AV-CSVL, AV-T1 correction and POTSI associated significantly with SRS-30 scores. Whereas, thoracic Cobb angle, Cobb correction, and coronal balance did not correlate with any patient-rated outcome measure. It is, therefore, inferred that the patients-rated subjective outcomes are only poorly reflected by the objectively measured radiographic and cosmetic measures of deformity correction.

Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.

BACKGROUND: The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. METHODS/DESIGN: The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. DISCUSSION: It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42281022.

Interference in the endplate nutritional pathway causes intervertebral disc degeneration in an immature porcine model.

PURPOSE: Previous studies have shown that blocking the endplate nutritional pathway with bone cement did not result in obvious intervertebral disc degeneration (IDD) in mature animal models. However, there are very few comparable studies in immature animal models. As vertebroplasty currently is beginning to be applied in young, even biologically immature patients, it is important to investigate the effect of cement blocking at the endplate in an immature animal model. METHODS: Two lumbar intervertebral discs in eight immature pigs were either blocked by cement in both endplate pathways or stabbed with a scalpel in the annulus fibrosus (AF) as a positive control, and with a third disc remaining intact as a normal control. Magnetic resonance imaging (MRI) and histology study were performed. RESULTS: After three months, the cement-blocked discs exhibited severe IDD, with the percentage of disc-height index (DHI), nucleus pulposus (NP) area, and NP T2 value significantly lower than the normal control. These IDD changes were histologically confirmed. Post-contrast MRI showed diseased nutritional diffusion patterns in the cement-blocked discs. Moreover, the degenerative changes of the cement-blocked discs exceeded those of the injured AF positive controls. CONCLUSIONS: The endplate nutritional pathway was interfered with and diseased after three months of bone cement intervention in an immature porcine model. Severe interference in the endplate nutritional pathway in an immature porcine model caused IDD. These findings also draw attention to the fact that interference in endplate nutritional pathways in immature or young patients may affect the vitality of adjacent discs.

A single topical dose of erythropoietin applied on a collagen carrier enhances calvarial bone healing in pigs.

BACKGROUND AND PURPOSE: The osteogenic potency of erythropoietin (EPO) has been documented. However, its efficacy in a large-animal model has not yet been investigated; nor has a clinically safe dosage. The purpose of this study was to overcome such limitations of previous studies and thereby pave the way for possible clinical application. Our hypothesis was that EPO increases calvarial bone healing compared to a saline control in the same subject. METHODS: We used a porcine calvarial defect model. In each of 18 pigs, 6 cylindrical defects (diameter: 1 cm; height: 1 cm) were drilled, allowing 3 pairwise comparisons. Treatment consisted of either 900 IU/mL EPO or an equal volume of saline in combination with either autograft, a collagen carrier, or a polycaprolactone (PCL) scaffold. After an observation time of 5 weeks, the primary outcome (bone volume fraction (BV/TV)) was assessed with high-resolution quantitative computed tomography. Secondary outcome measures were histomorphometry and blood samples. RESULTS: The median BV/TV ratio of the EPO-treated collagen group was 1.06 (CI: 1.02-1.11) relative to the saline-treated collagen group. Histomorphometry showed a similar median effect size, but it did not reach statistical significance. Autograft treatment had excellent healing potential and was able to completely regenerate the bone defect independently of EPO treatment. Bony ingrowth into the PCL scaffold was sparse, both with and without EPO. Neither a substantial systemic effect nor adverse events were observed. The number of blood vessels was similar in EPO-treated defects and saline-treated defects. INTERPRETATION: Topical administration of EPO on a collagen carrier moderately increased bone healing. The dosing regime was safe, and could have possible application in the clinical setting. However, in order to increase the clinical relevance, a more potent but still clinically safe dose should be investigated.

Long-term health care utilisation and costs after spinal fusion in elderly patients.

PURPOSE: Spinal fusion surgery rates in the elderly are increasing. Cost effectiveness analyses with relatively short-length follow-up have been performed. But the long-term effects in terms of health care use are largely unknown. The aim of the present study was to describe the long-term consequences of spinal fusion surgery in elderly patients on health care use and costs using a health care system perspective. METHODS: 194 patients undergoing spinal fusion between 2001 and 2005 (70 men, 124 women) with a mean age of 70 years (range 59-88) at surgery were included. Average length of follow-up was 6.2 years (range 0.3-9.0 years). Data on resource utilisation and costs were obtained from national registers providing complete coverage of all reimbursed contacts with primary- and secondary health care providers. Data were available from 3 years prior fusion surgery until the end of 2009. RESULTS: Use of hospital-based health care increased in the year prior to and the first year following surgery. Hereafter it normalised to the level of the background population and was mainly composed of diseases unrelated to the spine. In contrast, the use of primary health care appeared to increase immediately after surgery and continued to increase to a level that significantly exceeded that of the background population. It could be demonstrated that the increase was mainly due to an increasing number of general practitioner consultations. CONCLUSION: Spinal fusion surgery in older patients does not generate excess hospital-based health care use in the longer term as compared with the background population, but primary care use increases.

Short-term alendronate treatment does not maintain a residual effect on spinal fusion with interbody devices and bone graft after treatment withdrawal: an experimental study on spinal fusion in pigs.

PURPOSE: Whether alendronate treatment has a residual effect on bone ingrowth into porous biomaterial in humans or experimental animals after treatment withdrawal is still unknown. The purpose of this study was to investigate bone ingrowth into porous tantalum and carbon fiber interbody implants after discontinuing alendronate treatment in experimental spinal fusion in pigs. METHODS: Twenty-four pigs were randomly divided into two groups of each 12 pigs. The pigs underwent anterior intervertebral lumbar arthrodeses at L2-3, L4-5 and L6-7. Each level was randomly allocated to one of the three implants: a porous tantalum ring with pedicle screw fixation, a porous tantalum ring or a carbon fiber cage with anterior staple fixation. The central hole of implants was packed with an autograft. Alendronate was given orally for the first 3 months to one of the two groups. The pigs were observed for 6 months postoperatively. Histology and micro-CT scans were done at the endpoint. RESULTS: The spinal fusion rates of each implant showed no differences between two treatment groups. Furthermore, no differences were found between two groups as for bone ingrowth into the central holes of implants and bone-implant interface in each implant, or as for the pores of tantalum implants. Trabecular bone microarchitecture in the central hole of the carbon fiber cage did not differ between two treatment groups. CONCLUSION: The application of ALN, with a dose equivalent to that given to humans during the first 3 months after surgery, does not maintain a residual effect on spinal fusion with porous tantalum ring and autograft after treatment withdrawal in a porcine ALIF model.

Failure modes in conservative and surgical management of infectious spondylodiscitis.

PURPOSE AND METHODS: We reviewed the management, failure modes, and outcomes of 196 patients treated for infectious spondylodiscitis between January 1, 2000 and December 31, 2010, at the Spinal Unit, Aarhus University Hospital, Aarhus, Denmark. Patients with infectious spondylodiscitis at the site of previous spinal instrumentation, spinal metastases, and tuberculous and fungal spondylodiscitis were excluded. RESULTS: Mean age at the time of treatment was 59 (range 1-89) years. The most frequently isolated microorganism was Staphylococcus aureus. The lumbosacral spine was affected in 64% of patients and the thoracic in 21%. In 24% of patients, there were neurologic compromise, four had the cauda equina syndrome and ten patients were paraplegic. Ninety-one patients were managed conservatively. Treatment failed in 12 cases, 7 patients required re-admission, 3 in-hospital deaths occurred, and 5 patients died during follow-up. Posterior debridement with pedicle screw instrumentation was performed in 75, without instrumentation in 19 cases. Seven patients underwent anterior debridement alone, and in 16 cases, anterior debridement was combined with pedicle screw instrumentation, one of which was a two-stage procedure. Re-operation took place in 12 patients during the same hospitalization and in a further 12 during follow-up. Two in-hospital deaths occurred, and five patients died during follow-up. Patients were followed for 1 year after treatment. Eight (9%) patients treated conservatively had a mild degree of back pain, and one (1%) patient presented with mild muscular weakness. Among surgically treated patients, 12 (10%) had only mild neurological impairment, one foot drop, one cauda equine dysfunction, but 4 were paraplegic. Twenty-seven (23%) complained of varying degrees of back pain. CONCLUSIONS: Conservative measures are safe and effective for carefully selected patients without spondylodiscitic complications. Failure of conservative therapy requires surgery that can guarantee thorough debridement, decompression, restoration of spinal alignment, and correction of instability. Surgeons should master various techniques to achieve adequate debridement, and pedicle screw instrumentation may safely be used if needed.

Transforaminal lumbar interbody fusion (TLIF) versus posterolateral instrumented fusion (PLF) in degenerative lumbar disorders: a randomized clinical trial with 2-year follow-up.

PURPOSE: The aim of the present study was to analyze outcome, with respect to functional disability, pain, fusion rate, and complications of patients treated with transforaminal lumbar interbody fusion (TLIF) in compared to instrumented poserolateral fusion (PLF) alone, in low back pain. Spinal fusion has become a major procedure worldwide. However, conflicting results exist. Theoretical circumferential fusion could improve functional outcome. However, the theoretical advantages lack scientific documentation. METHODS: Prospective randomized clinical study with a 2-year follow-up period. From November 2003 to November 2008 100 patients with severe low back pain and radicular pain were randomly selected for either posterolateral lumbar fusion [titanium TSRH (Medtronic)] or transforaminal lumbar interbody fusion [titanium TSRH (Medtronic)] with anterior intervertebral support by tantalum cage (Implex/Zimmer). The primary outcome scores were obtained using Dallas Pain Questionnaire (DPQ), Oswestry disability Index, SF-36, and low back pain Rating Scale. All measures assessed the endpoints at 2-year follow-up after surgery. RESULTS: The overall follow-up rate was 94 %. Sex ratio was 40/58. 51 patients had TLIF, 47 PLF. Mean age 49(TLIF)/45(PLF). No statistic difference in outcome between groups could be detected concerning daily activity, work leisure, anxiety/depression or social interest. We found no statistic difference concerning back pain or leg pain. In both the TLIF and the PLF groups the patients had significant improvement in functional outcome, back pain, and leg pain compared to preoperatively. Operation time and blood loss in the TLIF group were significantly higher than in the PLF group (p < 0.001). No statistic difference in fusion rates was detected. CONCLUSIONS: Transforaminal interbody fusion did not improve functional outcome in patients compared to posterolateral fusion. Both groups improved significantly in all categories compared to preoperatively. Operation time and blood loss were significantly higher in the TLIF group.

Prevalence of complications in neuromuscular scoliosis surgery: a literature meta-analysis from the past 15 years.

PURPOSE: Our objectives were primarily to review the published literature on complications in neuromuscular scoliosis (NMS) surgery and secondarily, by means of a meta-analysis, to determine the overall pooled rates (PR) of various complications associated with NMS surgery. METHODS: PubMed and Embase databases were searched for studies reporting the outcomes and complications of NMS surgery, published from 1997 to May 2011. We focused on NMS as defined by the Scoliosis Research Society's classification. We measured the pooled estimate of the overall complication rates (PR) using a random effects meta-analytic model. This model considers both intra- and inter-study variation in calculating PR. RESULTS: Systematic review and meta-analysis were performed for 68 cohort and case-control studies with a total of 15,218 NMS patients. Pulmonary complications were the most reported (PR = 22.71 %) followed by implant complications (PR = 12.51 %), infections (PR = 10.91 %), neurological complications (PR = 3.01 %) and pseudoarthrosis (PR = 1.88 %). Revision, removal and extension of implant had highest PR (7.87 %) followed by malplacement of the pedicle screws (4.81 %). Rates of individual studies have moderate to high variability. The studies were heterogeneous in methodology and outcome types, which are plausible explanations for the variability; sensitivity analysis with respect to age at surgery, sample size, publication year and diagnosis could also partly explain this variability. In regard to surgical complications affiliated with various surgical techniques in NMS, the level of evidence of published literature ranges between 2+ to 2-; the subsequent recommendations are level C. CONCLUSION: NMS patients have diverse and high complication rates after scoliosis surgery. High PRs of complications warrant more attention from the surgical community. Although the PR of all complications are affected by heterogeneity, they nevertheless provide valuable insights into the impact of methodological settings (sample size), patient characteristics (age at surgery), and continual advances in patient care on complication rates.