Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis. A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Surgery versus conservative management in adult isthmic spondylolisthesis--a prospective randomized study: part 1. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. A prospective randomized comparison of 270 degrees fusions to 360 degrees fusions (circumferential fusions). Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study. ProDisc artificial total lumbar disc replacement: introduction and early results from the United States clinical trial. A randomized prospective study of posterolateral lumbar fusion. Outcomes with and without pedicle screw instrumentation. A prospective, randomized study of lumbar fusion. Preliminary results. 1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: a prospective, randomized clinical study. The use of primary internal fixation in spondylolisthesis. Degenerative lumbar spinal stenosis. Decompression with and without arthrodesis. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. Circumferential lumbar spinal fusion with Brantigan cage versus posterolateral fusion with titanium Cotrel-Dubousset instrumentation: a prospective, randomized clinical study of 146 patients. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. Outcome of the Graf ligamentoplasty procedure compared with anterior lumbar interbody fusion with the Hartshill horseshoe cage. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. Lumbar spine arthroplasty: early results using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain.
The purpose of this prospective study was to compare the effect of adjunctive direct current (DC) electrical stimulation and pulsed electromagnetic field therapy (PEMF) on augmentation of instrumented lumbar fusion. Sixty-one patients undergoing lumbar spine fusion were enrolled in the study and randomized to one of three treatment protocols: 1) adjunctive PEMF group (n = 22) fitted with Spinal-Stim model 8212(AME) within 30 days of surgery; 2) DC group (n = 17) had a SpF-2T stimulator(EBI) implanted at the time of surgery; or 3) control group (n = 22). The fusion mass bone mineral density (BMD) assessment was performed on 3-month and 1-year radiographs for each patient. Lateral flexion-extension and anteroposterior radiographs were evaluated at 1 year to determine the presence of fusion. Clinical outcome patient analyses were performed at 1 year. At 1-year follow-up, radiographic fusion and fusion mass bone density were not significantly different among the groups. In the nonstimulated group, there were 43% excellent, 43% good, and 14% fair results. In the PEMF group, there were 35% excellent, 50% good, 10% fair, and 5% poor results. In the DC group, there were 32% excellent, 37% good, and 31% fair results. The results of the current study suggest that electrical stimulation does not significantly enhance fusion rate in instrumented lumbar arthrodesis, although we observed a statistically insignificant trend toward increased fusion mass BMD in the electrically stimulated groups. The significance of increased BMD remains unknown. A prospective, randomized, controlled clinical trial comparing a cylindrical threaded titanium cage to a femoral ring allograft control for anterior lumbar interbody fusion.
                To compare these two implants with regard to arthrodesis. Secondary outcome measures included pain relief, neurological status, and general health status.
                Anterior lumbar interbody fusion is a well-accepted procedure using trapezoidal femoral ring allografts or cylindrical titanium cages. Clinical and biomechanical studies evaluating these two distinct constructs are numerous; however, no prospective, randomized study comparing them has been done.
                A multicenter trial of 140 patients: 78 were randomized to the cylindrical threaded titanium cage device treatment arm and 62 patients randomized into the control group. All had autogenous iliac crest bone graft packed into the device. All patients had a single-level stand-alone anterior lumbar interbody fusion at either the L4-L5 or L5-S1 interspace for symptomatic degenerative disc disease. Radiographic fusion data were collected as well as multiple types of outcome data, including pain/disability scores, neurologic status, and overall health.
                At 12 months, 97% of the cylindrical threaded titanium cage device group and 40% of the control group demonstrated radiographic fusion. At 24 months, 97% of the cylindrical threaded titanium cage group and 52% of the control group showed radiographic fusion. These fusion rate differences are statistically significant (P < 0.001). The Oswestry and neurologic scores were not significantly different between groups.
                This is the first prospective, randomized, multicenter clinical trial that compares fusion cage results to control data.
                Cylindrical threaded titanium cages have a higher fusion rate, comparable improvements in clinical outcome (Oswestry, Low Back Pain Questionnaire, SF-36), and fewer secondary supplemental fixation procedures compared to the femoral ring allograft control. Single blind randomized study.
                To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.
                To the authors' best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician.
                Sixty-four patients aged 25-60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4-L5 and/or L5-S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index.
                At the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (-6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rate according to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%.
                The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion. A prospective randomized study was performed.
                To determine whether posterolateral fusion in patients with adult isthmic spondylolisthesis results in an improved outcome compared with an exercise program.
                In spondylolisthesis, satisfactory results have been reported with both surgical and conservative management. The evidence for treatment efficacy, however, is weak because prospective randomized studies are lacking.
                In this study, 111 patients were randomly allocated to an exercise program (n = 34) or posterolateral fusion with or without transpedicular fixation (n = 77). The inclusion criteria were lumbar isthmic spondylolisthesis of any grade, at least 1 year of low back pain or sciatica, and a severely restricted functional ability in individuals 18 to 55 years of age. Pain and functional disability were quantified before treatment and at 1- and 2-year follow-up assessments by visual analog scales (VAS).
                The 2-year follow-up rate was 93%. The functional outcome, as assessed by the Disability Rating Index and the pain reduction, was better in the surgically treated group than in the exercise group at both the 1- and 2-year follow-up assessments (P < 0.01). In the longitudinal analysis, the mean Disability Rating Index and pain improved in the surgical group (P < 0.0001). In the exercise group, the Disability Rating Index did not change at all, whereas the pain decreased slightly (P < 0.02).
                Surgical management of adult isthmic spondylolisthesis improves function and relieves pain more efficiently than an exercise program. Between February 1985 and March 1990 44 patients with degenerative spondylolisthesis underwent primary surgery for spinal stenosis (in all cases the decompression preserved the facets bilaterally without discectomy) and were studied prospectively. Forty-three patients have been followed for > or = 2 years and are the basis of this study. There were three treatment groups: group I, no fusion (nine patients); group II, transverse process fusion with autogenous iliac bone graft without instrumentation (11 initial patients, with one lost to follow-up for a total of 10); and group III, transverse process fusion with autogenous iliac crest bone graft and instrumentation (24 patients, 18 with one-level pedicle fixation and six with two-level fixation). A higher proportion of group III subjects had a successful fusion compared with group II (p = 0.002). There was significantly more spondylolisthesis progression in groups I and II than in group III (p = 0.001). A higher proportion of "spondylolisthesis unchanged subjects" reported they were helped by the surgery than those whose spondylolisthesis progressed postoperatively (p < 0.01). Prospective randomized comparison of anterior lumbar interbody fusion (ALIF) plus transpedicular instrumentation plus posterolateral fusion (PLF) (360 degrees fusion) to ALIF plus transpedicular instrumentation without PLF (270 degrees fusion).
                To compare the clinical outcomes, costs, and utilization of health resources of 360 degrees versus 270 degrees fusions.
                The 360 degrees fusion is effective, but its costs and utilization of health resources are high. The PLF often resorbs and may not be necessary.
                Before and after surgery pain was measured by the Numerical Rating Scale (NRS), and function was measured by the Oswestry Low Back Disability Index (OSI). Costs were calculated by billing records. Operating times, blood loss, and hospital stays were measured at the time of hospital discharge.
                There were 48 patients: 21 women and 27 men. Mean age was 42 years. Follow-up averaged 35 months (range 24-45 months). In both 360 degrees and 270 degrees fusions, there were significant improvements in NRS and OSI, and the percentage of solid ALIF was high. Only 14% of PLF appeared solid bilaterally and 18% appeared solid on one side only. There were no significant differences in changes in NRS, changes in OSI, or percentage solid ALIF between the 360 degrees and 270 degrees fusions. However, the 270 degrees fusion group had significantly less blood loss, shorter operative times, shorter hospital stays, and lower professional fees, and although hospital charges were lower, this difference was not significant.
                Both the 360 degrees and 270 degrees fusions significantly reduce pain and improve function, and there are no significant clinical differences between them. However, there were shorter operating times, less blood loss, lower costs, and less utilization of health care resources associated with the 270 degrees fusions. The clinical study conducted was a prospective, randomized, double-blind, placebo-controlled trial.
                The purpose of this study was to evaluate the effect of combined magnetic fields on the healing of primary noninstrumented posterolateral lumbar spine fusion.
                Combined magnetic fields, a new type of biophysical stimulus, have been shown to act by stimulating endogenous production of growth factors that regulate the healing process. This is the first placebo-controlled study to assess the effect of an electromagnetic stimulus on primary noninstrumented posterolateral lumbar spine fusion surgery as well as the first evaluation of combined magnetic fields as an adjunctive stimulus to lumbar spine fusion.
                This multicenter investigational study was conducted at 10 clinical sites under an Investigational Device Exemption from the United States Food and Drug Administration. Eligible patients had one-level or two-level fusions (between L3 and S1) without instrumentation, either with autograft alone or in combination with allograft. The combined magnetic field device used a single posterior coil, centered over the fusion site, with one 30-minute treatment per day for 9 months. Randomization was stratified by site and number of levels fused. Evaluation was performed 3, 6, and 9 months after surgery and 3 months after the end of treatment. The primary endpoint was assessment of fusion at 9 months, based on radiographic evaluation by a blinded panel consisting of the treating physician, a musculoskeletal radiologist, and a spine surgeon.
                Of 243 enrolled patients, 201 were available for evaluation. Among all patients with active devices, 64% healed at 9 months compared with 43% of patients with placebo devices: a significant difference (P = 0.003 by Fisher's exact test). Stratification by gender showed fusion in 67% of women with active devices, compared with 35% of those with placebo devices (P = 0.001 by Fisher's exact test). By contrast, there was not a statistically significant effect of the active device in this male study population. In the overall population of 201 patients, repeated measures analyses of fusion outcomes (by generalized estimating equations) showed a main effect of treatment, favoring the active treatment (P = 0.030). In a model with main effect and a time by treatment interaction, the latter was significant (P = 0.024), indicating acceleration of healing. Performed in the full sample of 243 patients, results of the intent-to-treat analysis were qualitatively the same as in the evaluable sample of 201 patients.
                This investigational study demonstrates that combined magnetic field treatment of 30 min/d increases the probability of successful spine fusion, and statistical analysis using the generalized estimating equations model suggests an acceleration of the healing process. This is the first randomized clinical trial of noninstrumented primary posterolateral lumbar spine fusion, with evaluation by a blinded, unbiased panel. This is the first double-blind study performed to date assessing noninstrumented fusion outcome with extremely critical radiographic criteria. The lower overall fusion rates in this study are attributed to the high-risk patient group with an average age of 57 years, the use of noninstrumented technique with posterolateral fusion only, and the reliance on extremely critical radiographic and clinical criteria and blinded panel for fusion assessment without surgical confirmation.
                In conclusion, the adjunctive use of the combined magnetic field device was statistically beneficial in the overall patient population, as has been shown in previous studies of adjunctive bone growth stimulation for spine fusion. For the first time, stratification of fusion success data by gender demonstrated that the female study population responded positively to the adjunctive combined magnetic field treatment, with no statistically significant effect observed in the male study population. Adjunctive use of the combined magnetic field device significantly increased the 9-month success of radiographic spinal fusion and showed an acceleration of the healing process. Multicenter prospective randomized study of artificial disc replacement (ProDisc) versus circumferential fusion (standard of care) for one- and two-level degenerative disc disease. This is an interim analysis on patients seen at the Spine Institute Saint John's Health Center, Santa Monica, California.
                To evaluate early pain and functional outcomes of patients treated with disc replacement or fusion and to assess the capacity of this intervertebral disc replacement for preserving motion in the lumbar spine.
                Disc replacement is intended to reduce pain via removal of the diseased disc while restoring physiologic motion and height at the affected level. The long-term physiologic advantage of disc replacement to fusion is that preservation of motion may prevent additional degeneration at adjacent levels.
                Patients meeting inclusion criteria were consented for study. Randomization was performed using a 2 to 1 ratio of disc replacement procedure to a fusion procedure. Patients rated their pain on the Visual Analogue Scale and completed the Oswestry Disability Index questionnaire. Radiographs were taken. Assessments were made before surgery and after surgery at 6 weeks, 3 months, 6 months, and 1 year (ongoing). Changes from preoperative pain, disability, or motion were separately evaluated as a function of treatment using repeated measures mixed design analysis of variance.
                This analysis includes data up to 6 months from the first 53 randomized patients. There were 35 patients who underwent disc replacements, and 18 patients had fusion procedures. Disc replacement patients had a significant reduction in pain and disability at earlier evaluations. By 6 months, the relative improvement on both the Visual Analogue Scale and Oswestry (both, P < 0.05) were similar for disc replacement and fusion patients. Greater motion was found at L4-L5 for disc replacement patients (P < 0.05) than fusion patients. A similar trend was noted at L5-S1 (P was not significant).
                Disc replacement patients reported significantly less pain (Visual Analogue Scale) and disability (Oswestry) in the early period following surgery compared to fusion patients. This difference disappeared by 6 months. When compared to fusion, the disc replacement allowed preservation of motion at L4-L5 with a similar trend at L5-S1. A prospective evaluation of the clinical and radiographic outcomes of 71 patients who underwent lumbar fusion, with or without transpedicular instrumentation. The patients completed a questionnaire that determined pain relief, medication use, return to work, and overall satisfaction with surgery.
                To explore the effect, if any, of instrumentation on the outcome of lumbar fusion surgery, according to reports of the patients, and whether there is a correlation between the radiographic determination of a solid fusion and the same patient-reported outcome.
                The literature on this topic reports pseudarthrosis rates from 0% to 57% and good to excellent results from 56% to 95%. These studies provide no clear-cut recommendations concerning the effect of added lumbar instrumentation on patient-reported outcome in a prospective manner using concurrent control subjects.
                The patients were randomized to groups with and without instrumentation after deciding to undergo a lumbar fusion and consenting to enter the study. Radiographs were obtained and questionnaires filled out at 6 weeks, 6 months, 1 year, and 2 years after surgery.
                There was no statistical difference in patient-reported outcome between the two groups. There was a slight nonsignificant trend toward increased radiographic fusion rate in the group with instrumentation that did not correlate with an increased patient-reported improvement rate.
                These results do not provide data that indicate a benefit in outcome from added instrumentation in elective lumbar fusions. One hundred, twenty-four patients undergoing lumbar or lumbosacral fusion for degenerative conditions were entered into a prospective study. The patients were randomly assigned to one of three treatment groups. Group I underwent posterolateral fusion using autogenous bone graft. Group II had autogenous posterolateral fusions supplemented by a semi-rigid pedicle screw/plate fixation system (Luque II; Danek Medical, Memphis, Tennessee). Group III patients underwent posterolateral autogenous fusion with a rigid pedicle screw/rod fixation system (Texas Scottish Rite Hospital [TSRH]-Danek Medical, Memphis, Tennessee). All the patients were operated on by the same surgeon, identical bone grafting technique was used in all, and all were treated in an identical fashion postoperatively. Fusion status was determined from the anteroposterior, oblique, and flexion-extension radiographs obtained at 1 year. Clinical results were rated as excellent if the patients were pain-free and had returned to work; good if the patients had mild backache requiring non-narcotic analgesics and had returned to work; fair if continuing back pain prevented a return to work; or poor if the pain was worse than that which the patient experienced preoperatively or the patient required revision surgery. Nine patients who were originally assigned to Group II or Group III were placed in Group I intraoperatively. This change was due to the identification of severe osteopenia and the determination that pedicle screw purchase was poor. One patient was lost to follow-up. Thus, 51 patients were in Group I, 35 in Group II, and 37 in Group III. Follow-up ranged from 9 to 28 months, averaging 16 months.(ABSTRACT TRUNCATED AT 250 WORDS) A prospective randomized clinical study.
                To evaluate supplementary pedicle screw fixation (Cotrel-Dubousset) in posterolateral lumbar spinal fusion.
                The rationale behind lumbar fusion is to eliminate pathologic motion to relieve pain. To improve fusion rates and to allow reduction, a rigid transpedicular screw fixation may be beneficial, but the positive effect of this may be counter-balanced by an increase in complications.
                The inclusion criteria were severe, chronic low back pain from spondylolisthesis Grades 1 and 2 or from primary or secondary degenerative segmental instability. One hundred thirty patients were randomly allocated to receive no instrumentation (n = 66) or Cotrel-Dubousset instrumentation (n = 64) in posterolateral lumbar fusion. Variables were registered at the time of surgery and at 1 and 2 years after surgery.
                Follow-up was achieved in 97.7% of the patients. Fusion rates deduced from plain radiographs were not significantly different between instrumented and noninstrumented groups. The functional outcome assessed by the Dallas Pain Questionnaire improved significantly in both groups, and there were no significant differences in results between the two groups, except for significantly better (P < 0.06) functional outcome in relation to daily activities in the instrumented group when neural decompression had been performed. The global patients' satisfaction was 82% in the instrumented group versus 74% in the noninstrumented group (not significant). Fixation of instrumentation increased operation time, blood loss, and early reoperation rate significantly. Patients experienced only a few minor postoperative complications; none were major. Two infections appeared in the Cotrel-Dubousset group. Significant symptoms from misplacement of pedicle screws were seen in 4.8% of the instrumented patients.
                Lumbar posterolateral fusion with pedicle screw fixation increases the operation time, blood loss, and reoperation rate, and leads to a significant risk of nerve injury. The functional outcome improves significantly with high patient satisfaction, with or without instrumentation. No significant differences were observed between the two groups in functional outcome and fusion rate. The only gain in functional outcome from instrumentation was found in the daily activity category in patients with supplementary neural decompression. The results of this study do not justify the general use of pedicle screw fixation alone as an adjunct to posterolateral lumbar fusion. A prospective randomized study was designed to examine differences in the primary fusion rate between two surgically treated groups of patients with spondylolisthesis. Twenty-seven patients underwent L5 laminectomy (Gill procedure) and L5 nerve root decompression. Fourteen patients (group I) underwent in-situ posterolateral fusion, thirteen patients (group II) received internal stabilization with the Steffee plate and screw system. All patients were followed for a minimum of two years. Ten of fourteen (72%) patients treated with non-instrumented fusion went on to union. Ten of thirteen (78%) patients treated with internal fixation achieved union. No statistically significant increase in the primary fusion rate occurred with addition of internal fixation compared to non-instrumented posterolateral grafting alone. We prospectively evaluated the results of decompression of the spine, with and without arthrodesis, for the treatment of lumbar spinal stenosis without instability in forty-five patients (twenty-one men and twenty-four women) who had been managed between November 1989 and November 1990. The average age at the time of the operation was sixty-seven years (range, forty-eight to eighty-seven years). The patients were randomly assigned to one of three treatment groups (fifteen patients in each group) according to when they were admitted to the hospital. Group I was treated with decompression with laminotomy and medial facetectomy; Group II, with decompression and arthrodesis of the most stenotic segment; and Group III, with decompression and arthrodesis of all of the decompressed vertebral segments. All of the operations were performed by the same surgeon. The average duration of follow-up was twenty-eight months (range, twenty-four to thirty-two months). All three groups had a significant improvement in the distance that the patients were able to walk at the time of the latest follow-up examination compared with before the operation (p < 0.001 for Group I, p < 0.002 for Group II, and p < 0.005 for Group III). With the numbers available, there were no significant differences in the results among the three groups with regard to the relief of pain (p = 0.25 for Group I compared with Group II, p = 0.36 for Group II compared with Group III, and p = 0.92 for Group I compared with Group III).(ABSTRACT TRUNCATED AT 250 WORDS) A prospective double-blind randomized trial in 28 patients.
                To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain, functional disability, and physical impairment in patients with chronic discogenic low back pain.
                Chronic discogenic low back pain is a challenging problem in western countries. A treatment option is radiofrequency heating of the affected disc. Its clinical efficacy has never been formally tested in a controlled trial.
                Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs. Only patients with one putative painful level were selected and randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (n = 13) received a 90-second 70 C lesion of the intervertebral disc. Patients in the control group (n = 15) underwent the same procedure, but without use of radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator.
                Eight weeks after treatment, there was one success in the radiofrequency group (n = 13) and two in the control group (n = 15). The adjusted and unadjusted odds ratio was 0.5 and 1.1, respectively (not significant). Also, visual analog scores for pain, global perceived effect, and the Oswestry disability scale showed no differences between the two groups.
                Percutaneous intradiscal radiofrequency thermocoagulation (90 seconds, 70 C) is not effective in reducing chronic discogenic low back pain. Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. This study reports the results from a prospective, randomized trial of the X STOP conducted at nine centers in the U.S. Two hundred patients were enrolled in the study and 191 were treated; 100 received the X STOP and 91 received non-operative therapy (NON OP) as a control. The Zurich Claudication Questionnaire (ZCQ) was the primary outcomes measurement. Validated for lumbar spinal stenosis patients, the ZCQ measures physical function, symptom severity, and patient satisfaction. Patients completed the ZCQ upon enrollment and at follow-up periods of 6 weeks, 6 months, and 1 year. Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity. Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2.
                We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery.
                At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group.
                A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer.
                Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. A prospective randomized clinical study with a 2-year follow-up period was conducted.
                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.
                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.
                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.
                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%).
                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. This prospective study analyzed the influence of transpedicular instrumented on the operative treatment of patients with degenerative spondylolisthesis and spinal stenosis.
                To determine whether the addition of transpedicular instrumented improves the clinical outcome and fusion rate of patients undergoing posterolateral fusion after decompression for spinal stenosis with concomitant degenerative spondylolisthesis.
                Decompression is often necessary in the treatment of symptomatic patients who have degenerative spondylolisthesis and spinal stenosis. Results of recent studies demonstrated that outcomes are significantly improved if posterolateral arthrodesis is performed at the listhesed level. A meta-analysis of the literature concluded that adjunctive spinal instrumentation for this procedure can enhance the fusion rate, although the effect on clinical outcome remains uncertain.
                Seventy-six patients who had symptomatic spinal stenosis associated with degenerative lumbar spondylolisthesis were prospectively studied. All patients underwent posterior decompression with concomitant posterolateral intertransverse process arthrodesis. The patients were randomized to a segmental transpedicular instrumented or noninstrumented group.
                Sixty-seven patients were available for a 2-year follow-up. Clinical outcome was excellent or good in 76% of the patients in whom instrumentation was placed and in 85% of those in whom no instrumentation was placed (P = 0.45). Successful arthrodesis occurred in 82% of the instrumented cases versus 45% of the noninstrumented cases (P = 0.0015). Overall, successful fusion did not influence patient outcome (P = 0.435).
                In patients undergoing single-level posterolateral fusion for degenerative spondylolisthesis with spinal stenosis, the use of pedicle screws may lead to a higher fusion rate, but clinical outcome shows no improvement in pain in the back and lower limbs. A randomized controlled multicenter study with a 2-year follow-up by an independent observer.
                To determine whether fusion of the lower lumbar spine could reduce pain and diminish disability more effectively when compared with nonsurgical treatment in patients with severe chronic low back pain (CLBP).
                The reported results after fusion surgery on patients with CLBP vary considerably, and the evidence of treatment efficacy is weak in the absence of randomized controlled studies.
                A total of 294 patients referred to 19 spinal centers from 1992 through 1998 were randomized blindly into four treatment groups. Patients aged 25-65 years with CLBP for at least 2 years and with radiologic evidence of disc degeneration at L4-L5, L5-S1, or both were eligible to participate in the study. The surgical group (n=222) included three different fusion techniques, not analyzed separately in this study. Patients in the nonsurgical group (n=72) were treated with different kinds of physical therapy. The surgical group comprised 49.5% men, and the mean age was 43 years. The corresponding figures for the nonsurgical group were 48.6% and 44 years. The patients had suffered from low back pain for a mean of 7.8 and 8.5 years and been on sick leave due to back pain for a mean of 3.2 and 2.9 years, respectively. The Visual Analogue Scale (VAS) was used to measure pain. The Oswestry Low Back Pain Questionnaire, the Million Score and the General Function Score (GFS) were used to measure disability. The Zung Depression Scale was used to measure depressive symptoms. The overall result was assessed by the patient and by an independent observer. Records from the Swedish Social Insurance were used to evaluate work disability. Patients who changed groups were included in the analyses of significance according to the intention-to-treat principle.
                At the 2-year follow-up 289 of 294 (98%) patients, including 25 who had changed groups, were examined. Back pain was reduced in the surgical group by 33% (64 to 43), compared with 7% (63 to 58) in the nonsurgical group (P=0.0002). Pain improved most during the first 6 months and then gradually deteriorated. Disability according to Oswestry was reduced by 25% (47 to 36) compared with 6% (48 to 46) among nonsurgical patients (P=0.015), according to Million by 28% (64 to 46) compared with 8% (66 to 60) (P=0.004), and accordingtoGFS by 31% (49 to 34) compared with 4% (48 to 46) (P=0.005). The depressive symptoms, according to Zung, were reduced by 20% (39 to 31) in the surgical group compared with 7% (39 to 36) in the nonsurgical group (P=0.123). In the surgical group 63% (122/195) rated themselves as "much better" or "better" compared with 29% (18/62) in the nonsurgical group (P<0.0001). The "net back to work rate" was significantly in favor of surgical treatment, or 36% vs. 13% (P=0.002). The early complication rate in the surgical group was 17%.
                Lumbar fusion in a well-informed and selected group of patients with severe CLBP can diminish pain and decrease disability more efficiently than commonly used nonsurgical treatment. A randomized double-blind prospective comparison with a placebo control. This report of the results is the first in an ongoing study.
                To evaluate the effect of noninvasive capacitively coupled electrical stimulation on the success rate of lumbar spine fusion surgery, and to compare active with placebo stimulators as adjuncts to contemporary fusion techniques.
                Previous studies have established the effectiveness of direct current and electromagnetic field stimulation as adjuncts for some forms of spinal fusion. None of the previous placebo-controlled studies on external bone stimulation included posterolateral fusion techniques, and most were conducted with prior generations of internal fixation hardware.
                The investigation was conducted by 28 U.S. surgeons. Patients with a primary diagnosis of degenerative disc disease with or without other degenerative changes were selected. The study protocol defined success as a clinical outcome rated as excellent or good and a fusion documented as solid by both the investigator and the blinded independent radiologist. Disagreements on radiographic success were resolved by a second blinded independent reviewer.
                For the 179 patients who completed treatment and evaluation, the overall protocol success rate (both clinical and radiographic results rated as successes) was 84.7% for the active patients and 64.9% for the placebo patients. This difference is highly significant according to the Yates corrected chi-square test (P = 0.0043). Best improvements in patient outcomes (20% or greater success rate) occurred when active stimulation was used in conjunction with posterolateral fusion (P = 0.006) and when internal fixation also was incorporated (P = 0.013).
                This study was consistent in that active stimulation improved results for each stratification, although some strata had insufficient numbers of patients for the results to have statistical significance. Improved success rates when capacitively coupled stimulation is added to internal fixation are hypothesized to result from overcoming the biochemical effects of stress shielding.
                Capacitively coupled stimulation is an effective adjunct to primary spine fusion, especially for patients with posterolateral fusion and those with internal fixation. Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion.
                Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion-treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc-treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores.
                The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature. The objective of our study was to assess the efficacy of Graf ligamentoplasty in comparison with rigid fixation and fusion with the Hartshill horseshoe cage for similar severity of disc degeneration. Although studies have been done on the Graf ligamentoplasty procedure and the Hartshill horseshoe cage, their efficacy has never been compared in any study. This study was done to decide whether retaining mobility and stabilizing the spine is best or stiffening the lumbar segment by fusion is preferable. Between 1995 and 1997, a prospective randomized study was performed comparing Graf ligament stabilization and anterior lumbar interbody fusion. Twenty-eight patients had single-level Graf ligaments inserted and 27 patients had single-level anterior lumbar interbody fusion (ALIF) with a Hartshill horseshoe cage and tricortical iliac crest autograft. The two groups were similar in age, sex, symptoms, severity of the disc degeneration, and duration of follow-up. The chi-square test and t-test were used to evaluate the outcome. At a minimum follow-up of 2.1 years, we found that 93% of patients who had undergone Graf ligamentoplasty had a satisfactory outcome (rated "excellent" or "better") compared to 77.8% of patients who had been treated with ALIF with Hartshill horseshoe cage stabilization and fusion, when measured on the Oswestry Disability Index ( P<0.05). Retaining mobility in the lumbar segments gives better results after stabilisation with Graf ligaments than rigid fixation and fusion with the Hartshill horseshoe cage in the short term. We will be watching this cohort of patients over the next few years. A cohort of 100 patients with symptomatic lumbar spinal stenosis, characterized in a previous article, were given surgical or conservative treatment and followed for 10 years.
                To identify the short- and long-term results after surgical and conservative treatment, and to determine whether clinical or radiologic predictors for the treatment result can be defined.
                Surgical decompression has been considered the rational treatment. However, clinical experience indicates that many patients do well with conservative treatment.
                In this study, 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment, whereas 31 patients were randomized between the conservative (n = 18) and surgical (n = 13) treatment groups. Pain was decisive for the choice of treatment group. All patients were observed for 10 years by clinical evaluation and questionnaires. The results, evaluated by patient and physician, were rated as excellent, fair, unchanged, or worse.
                After a period of 3 months, relief of pain had occurred in most patients. Some had relief earlier, whereas for others it took 1 year. After a period of 4 years, excellent or fair results were found in half of the patients selected for conservative treatment, and in four fifths of the patients selected for surgery. Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months (median, 3.5 months). The treatment result of delayed surgery was essentially similar to that of the initial group. The treatment result for the patients randomized for surgical treatment was considerably better than for the patients randomized for conservative treatment. Clinically significant deterioration of symptoms during the final 6 years of the follow-up period was not observed. Patients with multilevel afflictions, surgically treated or not, did not have a poorer outcome than those with single-level afflictions. Clinical or radiologic predictors for the final outcome were not found. There were no dropouts, except for 14 deaths.
                The outcome was most favorable for surgical treatment. However, an initial conservative approach seems advisable for many patients because those with an unsatisfactory result can be treated surgically later with a good outcome. Fifty patients who had spinal stenosis associated with degenerative lumbar spondylolisthesis were prospectively studied clinically and radiographically to determine if concomitant intertransverse-process arthrodesis provided better results than decompressive laminectomy alone. There were thirty-six women and fourteen men. The mean age of the twenty-five patients who had had an arthrodesis was 63.5 years and that of the twenty-five patients who had not had an arthrodesis, sixty-five years. The level of the operation was between the fourth and fifth lumbar vertebrae in forty-one patients and between the third and fourth lumbar vertebrae in nine patients. The patients were followed for a mean of three years (range, 2.4 to four years). In the patients who had had a concomitant arthrodesis, the results were significantly better with respect to relief of pain in the back and lower limbs. This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status. There were 28 ProDisc patients and 11 who underwent fusion. Six patients had two-level surgery. Estimated blood loss (ProDisc = 69 mL versus fusion = 175 mL) and operative time (ProDisc = 75 minutes versus fusion = 219 minutes) were significantly different (P < 0.01). Hospital stays were shorter (ProDisc = 2.1 days versus fusion = 3.5 days [P < 0.01]) for ProDisc patients. There was a significantly greater reduction in the ODQ scores at 3 months in the ProDisc group compared with the fusion group (P < 0.05). No difference was noted in VAS. A trend was identified at 6 months in patient satisfaction rates favoring ProDisc versus fusion (P = 0.08), and motion was significantly improved in ProDisc patients compared with the fusion group (P = 0.02). Ambulatory status as well as recreational activity improved faster in the ProDisc group. The data suggest that total disc arthroplasty may be an attractive option as opposed to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease. A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established. Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.
                To compare the efficacy of IDET with that of a placebo treatment.
                Randomized, placebo-controlled, prospective trial.
                Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features.
                IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients.
                The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale.
                Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit.
                Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.
Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.