Instrumented Versus Uninstrumented Posterolateral Fusion for Lumbar Spondylolisthesis: A Randomized Controlled Trial.

BACKGROUND: In Scandinavia, spinal fusion is frequently performed without instrumentation, as use of instrumentation in the elderly can be complicated by poor bone quality and the risk of screw pull-out. However, uninstrumented fusion carries the risk of nonunion. We performed a randomized controlled trial in an attempt to determine if use of instrumentation leads to better outcomes and fusion rates when spinal fusion is performed for degenerative spondylolisthesis in the elderly. METHODS: This was a randomized, single-center, open-label trial of patients with symptomatic single-level degenerative spondylolisthesis who were assigned 1:1 to decompression and fusion with or without instrumentation after at least 12 weeks of nonoperative treatment had failed. The primary outcome was the change in the Oswestry Disability Index (ODI), and secondary outcomes included fusion rates within 1 year, reoperation rates within 2 years, and changes in the EuroQol-5 Dimension-3 Level (EQ-5D) score. RESULTS: Fifty-four subjects were randomized to each of the 2 groups, which had similar preoperative demographic and surgical characteristics. We found similar improvements in the ODI (p = 0.791), back pain, leg pain, and quality of life between groups at 1 and 2 years of follow-up. Solid fusion on computed tomography (CT) scans was noted in 94% of the patients in the instrumented group and 31% in the uninstrumented group (p < 0.001). One patient (2%) in the instrumented group and 7 (13%) in the uninstrumented group (p = 0.031) had a reoperation within 2 years after the index surgery. CONCLUSIONS: We found no difference in patient-reported outcomes when we compared instrumented with uninstrumented fusion in patients with degenerative spondylolisthesis. The uninstrumented group had a significantly higher rate of nonunion and reoperations at 2 years. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

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.

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 ).

Does a preoperative cognitive-behavioral intervention affect disability, pain behavior, pain, and return to work the first year after lumbar spinal fusion surgery?

STUDY DESIGN: A randomized clinical trial including 90 patients. OBJECTIVE: To examine the effect of a preoperative cognitive-behavioral intervention (CBT) for patients undergoing lumbar spinal fusion (LSF) surgery. SUMMARY OF BACKGROUND DATA: Few published studies have looked at the potential of rehabilitation to improve outcomes after LSF. Rehabilitation programs using CBT are recommended. Furthermore, initiating interventions preoperatively seems beneficial, but only limited data exist in the field of spine surgery. METHODS: Patients with degenerative disc disease or spondylolisthesis undergoing LSF were randomized to usual care (control group) or preoperative CBT and usual care (CBT group). Primary outcome was change in Oswestry Disability Index from baseline to 1-year follow-up. Secondary outcomes were catastrophizing, fear avoidance belief, work status, and back and leg pain. RESULTS: At 1-year follow-up, there was no statistically significant difference between the CBT group and the control group in Oswestry Disability Index score (P = 0.082). However, the CBT group had achieved a significant reduction of -15 points (-26; -4) already at 3 months (between group difference P = 0.003), and this reduction was maintained throughout the year. There were no differences between groups at 1-year follow-up with regard to any of the secondary outcomes. CONCLUSION: Participating in a preoperative CBT intervention in addition to usual care did not produce better outcomes at 1-year follow-up for patients undergoing LSF. Although the reduction in disability was achieved much faster in the CBT group, resulting in a significant difference between groups already 3 months after surgery, it did not translate into a faster return to work. Our findings support the need for further research into the use of targeted rehabilitation interventions among patients with elevated levels of catastrophizing and fear avoidance beliefs. LEVEL OF EVIDENCE: 2.

Degenerative spondylolisthesis is associated with low spinal bone density: a comparative study between spinal stenosis and degenerative spondylolisthesis.

Spinal stenosis and degenerative spondylolisthesis share many symptoms and the same treatment, but their causes remain unclear. Bone mineral density has been suggested to play a role. The aim of this study was to investigate differences in spinal bone density between spinal stenosis and degenerative spondylolisthesis patients. 81 patients older than 60 years, who underwent DXA-scanning of their lumbar spine one year after a lumbar spinal fusion procedure, were included. Radiographs were assessed for disc height, vertebral wedging, and osteophytosis. Pain was assessed using the Low Back Pain Rating Scale pain index. T-score of the lumbar spine was significantly lower among degenerative spondylolisthesis patients compared with spinal stenosis patients (-1.52 versus -0.52, P = 0.04). Thirty-nine percent of degenerative spondylolisthesis patients were classified as osteoporotic and further 30% osteopenic compared to only 9% of spinal stenosis patients being osteoporotic and 30% osteopenic (P = 0.01). Pain levels tended to increase with poorer bone status (P = 0.06). Patients treated surgically for symptomatic degenerative spondylolisthesis have much lower bone mass than patients of similar age treated surgically for spinal stenosis. Low BMD might play a role in the development of the degenerative spondylolisthesis, further studies are needed to clarify this.

Fusion mass bone quality after uninstrumented spinal fusion in older patients.

Older people are at increased risk of non-union after spinal fusion, but little is known about the factors determining the quality of the fusion mass in this patient group. The aim of this study was to investigate fusion mass bone quality after uninstrumented spinal fusion and to evaluate if it could be improved by additional direct current (DC) electrical stimulation. A multicenter RCT compared 40 and 100 µA DC stimulation with a control group of uninstrumented posterolateral fusion in patients older than 60 years. This report comprised 80 patients who underwent DEXA scanning at the 1 year follow-up. The study population consisted of 29 men with a mean age of 72 years (range 62-85) and 51 women with a mean age of 72 years (range 61-84). All patients underwent DEXA scanning of their fusion mass. Fusion rate was assessed at the 2 year follow-up using thin slice CT scanning. DC electrical stimulation did not improve fusion mass bone quality. Smokers had lower fusion mass BMD (0.447 g/cm(2)) compared to non-smokers (0.517 g/cm(2)) (P = 0.086). Women had lower fusion mass BMD (0.460 g/cm(2)) compared to men (0.552 g/cm(2)) (P = 0.057). Using linear regression, fusion mass bone quality, measured as BMD, was significantly influenced by gender, age of the patient, bone density of the remaining part of the lumbar spine, amount of bone graft applied and smoking. Fusion rates in this cohort was 34% in the control group and 33 and 43% in the 40 and 100 µA groups, respectively (not significant). Patients classified as fused after 2 years had significant higher fusion mass BMD at 1 year (0.592 vs. 0.466 g/cm(2), P = 0.0001). Fusion mass bone quality in older patients depends on several factors. Special attention should be given to women with manifest or borderline osteoporosis. Furthermore, bone graft materials with inductive potential might be considered for this patient population.

The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 1: functional outcome.

STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on functional and clinical outcome after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but functional outcome measures have not been reported. METHODS: A randomized, clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Functional outcome was assessed using Dallas Pain Questionnaire, SF-36, Low Back Pain Rating Scale pain index, and walking distance. RESULTS: Follow-up after 1 year was 95/107 (89%). DC-stimulated patients had significant better outcome in 3 of 4 categories in the Dallas Pain Questionnaire, better SF-36 scores (not significantly), but no difference in pain scores were observed. Median walking distance at latest follow-up was better in the stimulated group (not significant). Walking distance was significantly associated with functional outcome. There was no difference in any of the functional outcome scores between patients who experienced a perioperative complication and those without complications. CONCLUSION: The achievement of a good functional outcome was heavily dependent on the obtained walking distance. DC-stimulated patients tended to have better functional outcome as compared to controls. No negative effects of perioperative complications could be observed on the short-term functional outcome.

The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 2: fusion rates.

STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on fusion rates after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but little information exist on the effect in older patients. METHODS: A randomized clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Fusion rate was assessed at 2 year follow-up using thin slice CT. Functional outcome was assessed using Dallas Pain Questionnaire and Low Back Pain Rating Scale pain index. RESULTS.: Available follow-up after 2 years was 89% (84 of 95 patients). Fusion rates were surprisingly low. DC-stimulation had no effect on fusion rate: 35% versus 36% in controls. Other factors associated with low fusion rates were female gender (32% vs. 42% in males, P = 0.050) and smoking (21% vs. 42% in nonsmokers, P = 0.079). Patients who achieved a solid fusion as determined by CT had superior functional outcome and pain scores at their latest follow-up. CONCLUSION: Thin slice CT revealed very high nonunion rates after uninstrumented spinal fusion in older patients. DC-stimulation was not effective in increasing fusion rates in this patient population. The achievement of a solid fusion was associated with superior functional outcome.

[Cutaneous myiasis. A case of double infestation with Dermatobia hominis larvae]. / Kutan myiasis. Et tilfaelde af dobbelt infestation med fluelarven Dermatobia hominis.

We describe a case of imported double cutaneous infestation with Dermatobia hominis acquired in Central America. The characteristic clinical picture is a growing furuncular lesion with continuous secretion from a small central orifice. Because of the resemblance to a bacterial infection, there is a risk of diagnostic failure. Increasing incidence of imported myiasis may be expected as a result of increased travel activity to endemic areas. A certain knowledge of this disease is therefore required.