Persistent Opioid Use After Spine Surgery: A Prospective Cohort Study.

STUDY DESIGN: Single-center, investigator-initiated, prospective cohort study. OBJECTIVE: This study aimed to determine patient-reported reasons for persistent opioid use following elective spine surgery, assess the frequency of withdrawal symptoms, and characterize pain-related care sought after discharge. SUMMARY OF BACKGROUND DATA: Patients are often prescribed opioids at discharge from hospital following surgery. Several studies have shown that a large number of patients fail to discontinue opioid treatment and use opioids even months to years after surgery. Spine surgery has proven to be a high-risk procedure in regard to persistent opioid use. There is, however, limited evidence on why patients continue to take opioids. METHODS: Three hundred patients, scheduled to undergo spine surgery at Aarhus University Hospital, Denmark, were included. Baseline characteristics and discharge data on opioid consumption were collected. Data on opioid consumption, patient-reported reasons for opioid use, withdrawal symptoms, and pain-related care sought were collected at 3- and 6-month follow-up via a REDCap survey. RESULTS: Before surgery, opioid use was reported in 53% of patients. Three months after surgery, opioid use was reported in 60% of preoperative opioid-users and in 9% of preoperative opioid non-users. Patients reported the following reasons for postoperative opioid use: treatment of surgery-related pain (53%), treatment of surgery-related pain combined with other reasons (37%), and reasons not related to spine surgery (10%). Withdrawal symptoms were experienced by 33% of patients during the first 3 months after surgery and were associated with failure to discontinue opioid treatment (P < 0.001). Half of patients (52%) contacted health care after discharge with pain-related topics the first 3 months. CONCLUSION: Patients use opioids after spine surgery for reasons other than surgery-related pain. Withdrawal symptoms are frequent even though patients are given tapering plans at discharge. Further studies should address how to facilitate successful and safe opioid tapering in patients undergoing spine surgery.Level of Evidence: 3.

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.

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.

Improved patient selection by stratified surgical intervention: Aarhus Spinal Metastases Algorithm.

BACKGROUND CONTEXT: Choosing the best surgical treatment for patients with spinal metastases remains a significant challenge for spine surgeons. There is currently no gold standard for surgical treatments. The Aarhus Spinal Metastases Algorithm (ASMA) was established to help surgeons choose the most appropriate surgical intervention for patients with spinal metastases. PURPOSE: The purpose of this study was to evaluate the clinical outcome of stratified surgical interventions based on the ASMA, which combines life expectancy and the anatomical classification of patients with spinal metastases to inform surgical decision making. STUDY DESIGN/SETTING: This is a retrospective study based on a prospective database. PATIENT SAMPLE: A consecutive series of 515 spinal metastatic patients who underwent surgically treatment from December 1992 to June 2012 in Aarhus University Hospital were included prospectively and analyzed in detail retrospectively. OUTCOME MEASURES: Survival time after surgery was determined for all patients. Neurological function was assessed using the Frankel score preoperatively and postoperatively (at the time of discharge). Complete outcome data were retrieved in 97.5% of this cohort. METHODS: Patients with spinal metastases were identified from an institutional database that prospectively collected data since 1992. Survival status data were obtained from a national registry. Neurological function was determined from the same institutional database or local Electronic Patient Journal system. Surgeons evaluated and classified patients into five surgical groups preoperatively by using the revised Tokuhashi score (TS) and the Tomita anatomical classification (TC). RESULTS: The overall median survival time of the cohort was 6.8 (95% confidence interval: 6.1-7.9) months. The median survival times in the five surgical groups determined by the ASMA were 2.1 (TS 0-4, TC 1-7), 5.1 (TS 5-8, TC 1-7), 12.1 (TS 9-11, TC 1-7 or TS 12-15, TC 7), 26.0 (TS 12-15, TC 4-6), and 36.0 (TS 12-15, TC 1-3) months. The 30-day mortality rate was 7.5%. Postoperative neurological function was maintained or improved in 469 patients (92.3%). Overall reoperation rate was 13.5%, commonly because of postoperative hematoma and new limb weakness. CONCLUSIONS: The ASMA recommends at least two surgical options for a particular patient by determining the preoperative life expectancy and anatomical classification of the spinal metastases. This algorithm could help spine surgeons to discriminate the risks of surgeries. The ASMA provides a tool to guild surgeons to evaluate the spinal metastases patients, select potential optimal surgery, and avoid life-threatening risks.

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.

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.

Predictive value of Tokuhashi scoring systems in spinal metastases, focusing on various primary tumor groups: evaluation of 448 patients in the Aarhus spinal metastases database.

STUDY DESIGN: We conducted a prospective cohort study of 448 patients with spinal metastases from a variety of cancer groups. OBJECTIVE: To determine the specific predictive value of the Tokuhashi scoring system (T12) and its revised version (T15) in spinal metastases of various primary tumors. SUMMARY OF BACKGROUND DATA: The life expectancy of patients with spinal metastases is one of the most important factors in selecting the treatment modality. Tokuhashi et al formulated a prognostic scoring system with a total sum of 12 points for preoperative prediction of life expectancy in 1990 and revised it in 2005 to a total sum of 15 points. There is a lack of knowledge about the specific predictive value of those scoring systems in patients with spinal metastases from a variety of cancer groups. METHODS: We included 448 patients with vertebral metastases who underwent surgical treatment during November 1992 to November 2009 in Aarhus University Hospital NBG. Data were retrieved from Aarhus Metastases Database. Scores based on T12 and T15 were calculated prospectively for each patient. We divided all the patients into different groups dictated by the site of their primary tumor. Predictive value and accuracy rate of the 2 scoring systems were compared in each cancer group. RESULTS: Both the T12 and T15 scoring systems showed statistically significant predictive value when the 448 patients were analyzed in total (T12, P < 0.0001; T15, P < 0.0001). The accuracy rate was significantly higher in T15 (P < 0.0001) than in T12. The further analyses by primary cancer groups showed that the predictive value of T12 and T15 was primarily determined by the prostate (P = 0.0003) and breast group (P = 0.0385). Only T12 displayed predictive value in the colon group (P = 0.0011). Neither of the scoring systems showed significant predictive value in the lung (P > 0.05), renal (P > 0.05), or miscellaneous primary tumor groups (P > 0.05). The accuracy rate of prognosis in T15 was significantly improved in the prostate (P = 0.0032) and breast group (P < 0.0001). CONCLUSION: Both T12 and T15 showed significant predictive value in patients with spinal metastases. T15 has a statistically higher accuracy rate than T12. Among the various cancer groups, the 2 scoring systems are especially reliable in prostate and breast metastases groups. T15 is recommended as superior to T12 because of its higher accuracy rate.

The predictive value of pain drawings in lumbar spinal fusion surgery.

BACKGROUND CONTEXT: Pain drawings have been used extensively in spine surgery. It has been associated with inferior outcome after disc and stenosis surgery. Results regarding the predictive value in fusion surgery have been conflicting. PURPOSE: To evaluate the predictive value of pain drawings in relation to outcome after lumbar spinal fusion. To investigate if there are differences between spondylolisthesis patients and patients with degenerative disease as well as between patients with or without radicular pain. STUDY DESIGN: Prospective clinical cohort with a minimum of 1-year follow-up. PATIENT SAMPLE: One hundred thirty-five patients undergoing lumbar spinal fusion. Fifty-seven men and 78 women, mean age 44 years (range 21-59 years). OUTCOME MEASURES: Dallas Pain Questionnaire (DPQ), Low Back Pain Rating Scale (LBPRS) pain index and patient satisfaction. Minimal clinical important difference was defined for the LBPRS score. METHODS: Pain drawings were classified, using the visual inspection method, as organic or nonorganic and correlated to outcomes. Multivariate adjustment for several possible confounding variables was done using logistic regression analysis. RESULTS: Thirty-three percent of the drawings were classified as nonorganic. Nonorganic drawings were associated with significantly higher DPQ and LBPRS scores preoperatively and at follow-up. Differences between organic and nonorganic drawings were larger in spondylolisthesis patients than in patients with degenerative disorders. Nonorganic pain drawings were associated with poorer outcome in patients with low back pain and radicular symptoms, however, not in patients without radicular symptoms. A nonorganic pain drawing predicted negative patient satisfaction with odds ratio (OR) 3.01 (95% confidence interval (CI): 1.14-8.55, p=.027) but had no significant predictive value with respect to improvement in the LBPRS pain index OR 1.92 (95% CI: 0.82-4.47, p=.132). CONCLUSIONS: A nonorganic pain drawing was a significant risk factor for inferior outcome after spinal fusion surgery. The predictive value did not allow for patient selection.

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.

Impact of instrumentation in lumbar spinal fusion in elderly patients: 71 patients followed for 2-7 years.

BACKGROUND AND PURPOSE: An increasing number of lumbar fusions are performed using allograft to avoid donor-site pain. In elderly patients, fusion potential is reduced and the patient may need supplementary stability to achieve a solid fusion if allograft is used. We investigated the effect of instrumentation in lumbar spinal fusion performed with fresh frozen allograft in elderly patients. METHODS: 94 patients, mean age 70 (60-88) years, who underwent posterolateral spinal fusion either non-instrumented (51 patients) or instrumented (43 patients) were followed for 2-7 years. Functional outcome was assessed with the Dallas pain questionnaire (DPQ), the low back pain rating scale pain index (LBPRS), and SF-36. Fusion was assessed using plain radiographs. RESULTS: Instrumented patients had statistically significantly better outcome scores in 6 of 7 parameters. Fusion rate was higher in the instrumented group (81% vs. 68%, p = 0.1). Solid fusion was associated with a better functional outcome at follow-up (significant in 2 of 7 parameters). 15 patients (6 in the non-instrumented group and 9 in the instrumented group) had repeated lumbar surgery after their initial fusion procedure. Functional outcome was poorer in the group with additional spine surgeries (significant in 4 of 7 parameters). INTERPRETATION: Superior outcomes after lumbar spinal fusion in elderly patients can be achieved by use of instrumentation in selected patients. Outcome was better in patients in which a solid fusion was obtained. Instrumentation was associated with a larger number of additional surgeries, which resulted in a lesser degree of improvement. Instrumentation should not be discarded just because of the age of the patient.

Spondylodiscitis. A retrospective study of 163 patients.

BACKGROUND AND PURPOSE: Spondylodiscitis may be a serious disease due to diagnostic delay and inadequate treatment. There is no consensus on when and how to operate. We therefore retrospectively analyzed the outcome of a large series of patients treated either nonoperatively or surgically. PATIENTS AND METHODS: Between 1992 and 2000, 163 patients (101 males) were hospitalized due to spondylodiscitis. The mean age was 56 (1-83) years. The infection was located in the cervical spine in 13 patients (8%), in the thoracic spine in 62 patients (38%), at the thoracolumbar junction in 10 patients (6%), and in the lumbo-sacral spine in 78 patients (48%). In 67 patients (41%), no microorganisms were detected. Most of the other patients had Staphylococcus aureus infection (53 patients) and/or Mycobacterium tuberculosis (22 patients). The patients were divided into 3 groups: (A) 70 patients who had nonoperative treatment, (B) 56 patients who underwent posterior decompression alone, and (C) 37 patients who underwent decompression and stabilization. RESULTS: At 12-month follow-up, nonoperative treatment (A) had failed in 8/70 patients, who had subsequently been operated. 24/56 and 6/37 had been reoperated in groups B and C, respectively. Group A patients had no neurological symptoms. In group B, 11 had neurological deficits and surgery was beneficial for 5 of them; 4 remained unchanged and 2 deteriorated (1 due to cerebral abscess). 11 patients in group C had altered neurogical deficits, which improved in 9 of them. 20 patients had died during the 1-year follow-up, 3 in hospital, directly related with infection. INTERPRETATION: Nonoperative treatment was effective in nine-tenths of the patients. Decompression alone had high a reoperation rate compared to decompression and internal stabilization.

Circumferential fusion improves outcome in comparison with instrumented posterolateral fusion: long-term results of a randomized clinical trial.

STUDY DESIGN: Prospective randomized clinical study with a 5- to 9-year follow-up period. OBJECTIVE: The aim of the present study was to analyze the long-term outcome with respect to functional disability, pain, and general health of patients treated by means of circumferential lumbar fusion in comparison with those treated by means of instrumented posterolateral lumbar fusion. SUMMARY OF BACKGROUND DATA: Circumferential fusion has become a common procedure in lumbar spinal fusion both as a primary and salvage procedure. However, the claimed advantages of circumferential fusion over conventional posterolateral fusion lack scientific documentation. (The primary report with a 2-year follow-up has been published in Spine in 2002.) METHODS: From April 1996 to November 1999, a total of 148 patients (mean age, 45 years) with severe chronic low back pain were randomly selected for either posterolateral lumbar fusion (titanium Cotrel-Dubousset) or circumferential lumbar fusion (instrumented posterolateral fusion with anterior intervertebral support by a Brantigan cage). The primary outcome measure was the Dallas Pain Questionnaire (DPQ). The secondary outcome measures were the Oswestry Disability Index, the SF-36 instrument, and the Low Back Pain Rating Scale. All measures assessed the endpoint outcomes at 5 to 9 years after surgery. RESULTS: The available response rate was 93%. The circumferential group showed a significantly better improvement (P < 0.05) in comparison with the posterolateral group with respect to all four DPQ categories: daily activities, work/leisure, anxiety/depression, and social interest. The Oswestry Disability Index supported these results (P < 0.01). General health, as assessed by means of the SF-36, also showed significantly better physical health (P < 0.01) in the circumferential group, whereas no significant difference was found with respect to mental health compared with the posterolateral group. The circumferential group experienced significantly less back pain (P < 0.05) in comparison with the posterolateral group. In regard to leg pain, no significant difference was found. CONCLUSION: Circumferential lumbar fusion demands more extensive operative resources compared with posterolateral lumbar fusion. However, 5 to 9 years after surgery, the circumferentially fused patients had a significantly improved outcome compared with those treated by means of posterolateral fusion. These new results not only emphasize the superiority of circumferential fusion in the complex pathology of the lumbar spine but are also strongly supported in all of the validated questionnaires used in the study.

Circumferential lumbar spinal fusion with Brantigan cage versus posterolateral fusion with titanium Cotrel-Dubousset instrumentation: a prospective, randomized clinical study of 146 patients.

STUDY DESIGN: A prospective randomized clinical study with a 2-year follow-up period was conducted. OBJECTIVE: To analyze the effects of circumferential fusion using ALIF radiolucent carbon fiber cages and titanium posterior instrumentation on functional outcome, fusion rate, complications, and lumbar lordosis. SUMMARY OF BACKGROUND DATA: Circumferential fusion has become a common procedure in lumbar spine fusion, both as a primary and salvage procedure. However, the claimed advantages of ALIF plus PLF over conventional PLF lack scientific documentation. METHODS: From April 1996 through November 1999, a total of 148 patients with severe chronic low back pain were randomly selected for either posterolateral lumbar fusion with titanium CD-Horizon (posterolateral group) or circumferential fusion with a ALIF Brantigan cage plus posterior instrumentation. The Dallas Pain Questionnaire (DPQ), the Low Back Pain Rating Scale (LBPR), and a questionnaire concerning work status assessed their outcomes. RESULTS: Both groups showed highly significant improvement in all four categories of life quality (DPQ) as well as in the back pain and leg pain index (LBPR), as compared with preoperative status. There was a clear tendency toward better overall functional outcome for patients with the circumferential procedure ( < 0.08), and this patient group also showed significantly less leg pain at the 1-year follow-up evaluation ( < 0.03) and less peak back pain at 2 years ( < 0.04). Sagittal lordosis was restored and maintained in the circumferential group ( < 0.01). The circumferential fusion patients showed a higher posterolateral fusion rate (92%) than the posterolateral group (80%)( < 0.04). The repeat operation rate including implant removal was significantly lower in the circumferential group (7%) ( < 0.009) than in the posterolateral group (22%). CONCLUSIONS: Circumferential lumbar fusion restored lordosis, provided a higher union rate with significantly fewer repeat operations, showed a tendency toward better functional outcome, and resulted in less peak back pain and leg pain than instrumented posterolateral fusion. The clinical perspective of the current study implies a recommendation to favor circumferential fusion as a definitive surgical procedure in complex lumbar pathology involving major instability, flatback, and previous disc surgery in younger patients, as compared with posterolateral fusion with pedicle screws alone.