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.

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.

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.

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.