Branko Kopjar

Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study.

BACKGROUND Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition. METHODS Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score ≥ 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated. RESULTS Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups. CONCLUSIONS Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series.

Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study

OBJECT Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM. METHODS Data from the AOSpine North America Cervical Spondylotic Myelopathy Study, a prospective, multicenter study, were analyzed. Outcomes data, including adverse events, were collected in a standardized manner and externally monitored. Rates of perioperative complications (within 30 days of surgery) and delayed complications (31 days to 2 years following surgery) were tabulated and stratified based on clinical factors. RESULTS The study enrolled 302 patients (mean age 57 years, range 29-86) years. Of 332 reported adverse events, 73 were classified as perioperative complications (25 major and 48 minor) in 47 patients (overall perioperative complication rate of 15.6%). The most common perioperative complications included minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection (2.3%). Perioperative worsening of myelopathy was reported in 4 patients (1.3%). Based on 275 patients who completed 2 years of follow-up, there were 14 delayed complications (8 minor, 6 major) in 12 patients, for an overall delayed complication rate of 4.4%. Of patients treated with anterior-only (n = 176), posterior-only (n = 107), and combined anterior-posterior (n = 19) procedures, 11%, 19%, and 37%, respectively, had 1 or more perioperative complications. Compared with anterior-only approaches, posterior-only approaches had a higher rate of wound infection (0.6% vs 4.7%, p = 0.030). Dysphagia was more common with combined anterior-posterior procedures (21.1%) compared with anterior-only procedures (2.3%) or posterior-only procedures (0.9%) (p < 0.001). The incidence of C-5 radiculopathy was not associated with the surgical approach (p = 0.8). The occurrence of perioperative complications was associated with increased age (p = 0.006), combined anterior-posterior procedures (p = 0.016), increased operative time (p = 0.009), and increased operative blood loss (p = 0.005), but it was not associated with comorbidity score, body mass index, modified Japanese Orthopaedic Association score, smoking status, anterior-only versus posterior-only approach, or specific procedures. Multivariate analysis of factors associated with minor or major complications identified age (OR 1.029, 95% CI 1.002-1.057, p = 0.035) and operative time (OR 1.005, 95% CI 1.002-1.008, p = 0.001). Multivariate analysis of factors associated with major complications identified age (OR 1.054, 95% CI 1.015-1.094, p = 0.006) and combined anterior-posterior procedures (OR 5.297, 95% CI 1.626-17.256, p = 0.006). CONCLUSIONS For the surgical treatment of CSM, the vast majority of complications were treatable and without long-term impact. Multivariate factors associated with an increased risk of complications include greater age, increased operative time, and use of combined anterior-posterior procedures.

Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis.

BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer.

Early complications of surgical versus conservative treatment of isolated type II odontoid fractures in octogenarians: A retrospective cohort study

Study Design A retrospective cohort study of operative versus nonoperative treatment of isolated type II odontoid fractures in patients aged 80 years and more without neurologic deficit admitted to a level 1 spinal cord injury center between June 1985 and July 2006. Objective To assess the presentation and acute complications of operatively and nonoperatively managed type II odontoid fractures in the octogenarian population. Summary of Background Data Type II odontoid fractures are the most common cervical spine fracture in the elderly. Studies suggest acute in-hospital complication rates in type II odontoid fractures in the elderly exceed 50%. Few studies have examined the acute in-hospital outcomes of isolated type II odontoid fractures in the octogenarian population. Methods The medical records of 223 consecutive C2 fractures from June 1985 to July 2006 over the age of 80 years were reviewed retrospectively. Patients with associated cervical spine fractures were excluded. Eighty neurologically intact patients over age 80 were identified with isolated acute type II odontoid fractures. The charts were reviewed and mechanism of injury, comorbidities, date of injury, date of admission, date of discharge, radiology reports, discharge disposition, associated injuries, fracture management, type of surgical fixation (if any), and documented complications were abstracted. Results Thirty-two patients received operative treatment (10 anterior and 22 posterior) and 40 patients received nonsurgical treatment. Eight patients were excluded because the medical record could not be located. The mean age was 85.5±3.5 years in the surgical and 87.3±4.7 years in the nonsurgical group (P>0.05); mean length of acute hospital stay was 11.2±8.5 days in the nonsurgical and 22.8±28.3 days in the surgical group (P<0.05); mean comorbidity score was 2.3±1.2 in the nonsurgical and 2.0±1.0 in the surgical group (P>0.5); mean fracture displacement was 4.1±3.5 mm in the nonsurgical and 3.9±3.4 mm in the surgical group (P>0.5). Acute in-hospital mortality rate was 15% in the nonsurgical group and 12.5% in the surgical group (P>0.05). The percentage of patients experiencing at least one significant complication was higher in the operative group than the nonoperative group (62% vs. 35%, respectively, P<0.05). Conclusions Type II odontoid fractures in the octogenarian population are associated with substantial morbidity and mortality, irrespective of management method. Prospective studies are needed to better elucidate management strategies for this difficult clinical problem.

The AOSpine North America Geriatric Odontoid Fracture Mortality Study A Retrospective Review of Mortality Outcomes for Operative Versus Nonoperative Treatment of 322 Patients With Long-Term Follow-up

Study Design. Retrospective, multicenter cohort study. Objective. Assess for differences in short- and long-term mortality between operative and nonoperative treatment for elderly patients with type II odontoid fractures. Summary of Background Data. There is controversy regarding whether operative or nonoperative management is the best treatment for elderly patients with type II odontoid fractures. Methods. This is a retrospective study of consecutive patients aged 65 years or older with type II odontoid fracture from 3 level I trauma centers from 2003–2009. Demographics, comorbidities, and treatment were abstracted from medical records. Mortality outcomes were obtained from medical records and a public database. Hazard ratios (HRs) and 95% confidence intervals (CI) were calculated. Results. A total of 322 patients were included (mean age, 81.8 yr; range, 65.0–101.5 yr). Compared with patients treated nonoperatively (n = 157), patients treated operatively (n = 165) were slightly younger (80.4 vs. 83.2 yr, P = 0.0014), had a longer hospital (15.0 vs. 7.4 d, P < 0.001) and intensive care unit (1.5 vs. 1.1 d, P = 0.008) stay, and were more likely to receive a feeding tube (18% vs. 5%, P = 0.0003). Operative and nonoperative treatment groups had similar sex distribution (P = 0.94) and Charlson comorbidity index (P = 0.11). Within 30 days of presentation, 14% of patients died, and at maximal follow-up (average = 2.05 yr; range = 0 d–7.02 yr), 44% had died. On multivariate analysis, nonoperative treatment was associated with higher 30-day mortality (HR = 3.00, 95% CI = 1.51–5.94, P = 0.0017), after adjusting for age (HR = 1.10, 95% CI = 1.05–1.14; P < 0.0001), male sex (P = 0.69), and Charlson comorbidity index (P = 0.16). At maximal follow-up, there was a trend toward higher mortality associated with nonoperative treatment (HR = 1.35, 95% CI = 0.97–1.89, P = 0.079), after adjusting for age (HR = 1.07, 95% CI = 1.05–1.10; P < 0.0001), male sex (HR = 1.55, 95% CI = 1.10–2.16; P = 0.012), and Charlson comorbidity index (HR = 1.28, 95% CI = 1.16–1.40; P < 0.0001). Conclusion. Surgical treatment of type II odontoid fracture in this elderly population did not negatively impact survival, even after adjusting for age, sex, and comorbidities. The data suggest a significant 30-day survival advantage and a trend toward improved longer-term survival for operatively treated over nonoperatively treated patients. Level of Evidence: 4

Characterizing the Functional Improvement After Total Shoulder Arthroplasty for Osteoarthritis

Background: Both shoulder surgeons and patients who are considering total shoulder arthroplasty are interested in the anticipated improvement in shoulder comfort and function after the procedure. The purpose of the present study was to characterize shoulder-specific functional gains in relation to preoperative shoulder function and to present this information in a way that can be easily communicated to patients who are considering this surgery.Methods: We analyzed the preoperative and follow-up shoulder function in patients managed with total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis. Functional self-assessments were available for 102 (80%) of 128 shoulders after thirty to sixty months of follow-up. Outcome was assessed with respect to the change in the number of shoulder functions that were performable, the change in shoulder function as a percentage of the preoperative functional deficit, and the change in the ability to perform specific shoulder functions.Results: The average number of shoulder functions that were performable improved from four of twelve preoperatively to nine of twelve postoperatively (p < 0.01). Function improved in ninety-six shoulders (94%). The number of functions that were performable at the time of follow-up was positively associated with preoperative shoulder function (p < 0.05): the better the preoperative function, the better the follow-up function. The improvement in function was greatest for shoulders with less preoperative function (p < 0.01). On the average, patients regained approximately two-thirds of the functions that had been absent preoperatively. Significant improvement was noted in eleven of the twelve shoulder functions that were examined (p < 0.01). The chance of regaining a function that had been absent before surgery was 73%, whereas the chance of losing a function that had been present before surgery was 6%. Older men tended to have greater functional improvement than younger men.Conclusion: Total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis significantly improves shoulder function. Postoperative function is related to preoperative function. The improvement that was observed in this clinical series can be conveyed to patients most simply by stating that, after surgery, shoulders typically regained approximately two-thirds of the functions that had been absent preoperatively.

Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: Outcomes of the prospective multicenter AOSpine north America CSM study in 264 patients

Study Design. A prospective observational multicenter study. Objective. To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM). Summary of Background Data. The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches. We present an analysis of a prospective observational multicenter study examining outcomes of surgical treatment for CSM. Methods. A total of 278 subjects from 12 sites in North America received anterior/posterior or combined surgery at the discretion of the surgeon. This study focused on subjects who had either anterior or posterior surgery (n = 264, follow-up rate, 87%). Outcome measures included the modified Japanese Orthopedic Assessment scale, the Nurick scale, the Neck Disability Index, and the Short-Form 36 (SF-36) Health Survey version 2 Physical and Mental Component Scores. Results. One hundred and sixty-nine patients were treated anteriorly and 95 underwent posterior surgery. Anterior surgical cases were younger and had less severe myelopathy as assessed by mJOA and Nurick scores. There were no baseline differences in Neck Disability Index or SF-36 between the anterior and posterior cases. Improvement in the mJOA was significantly lower in the anterior group than posterior group (2.47 vs. 3.62, respectively, P < 0.01), although the groups started at different levels of baseline impairment. The extent of improvement in the Nurick Scale, Neck Disability Index, SF-36 version 2 Physical Component Score, and SF-36 version 2 Mental Component Score did not differ between the groups. Conclusion. Patients with CSM show significant improvements in several health-related outcome measures with either anterior or posterior surgery. Importantly, patients treated with anterior techniques were younger, with less severe impairment and more focal pathology. We demonstrate for the first time that, when patient and disease factors are controlled for, anterior and posterior surgical techniques have equivalent efficacy in the treatment of CSM. Level of Evidence: 3

Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture.

BACKGROUND Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older. METHODS One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables. RESULTS The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p < 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059). CONCLUSIONS We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates.

Fractures among children: incidence and impact on daily activities

Objectives—The studys objective was to examine incidence of fractures and associated activity restriction among children aged 0–12 years. Design—Injuries were prospectively recorded over the four year period from 1992–95 in a cohort of children aged 0–12 years, representing 193 540 children years. Information about length and extent of activity restriction was collected from parents by a mailed questionnaire for a subsample of 192 children with a fracture. Results—A total of 2477 fractures occurred in the study population (128 per 10 000 children annually). The incidence increased linearly with age, by 14 cases per 10 000 children year for each year of age. Boys and girls showed similar patterns of fracture occurrence. There was a significant difference in length of activity restrictions for different types of fractures. The mean and 95% confidence interval (CI) of activity restricted days for leg fractures were 26 (95% CI 7 to 45) days, for arm fractures, 14 (95% CI 8 to 20) days, and for other fractures, 5 (95% CI 1 to 8) days. Arm fractures represented 66% of the cases and 62% of the activity restricted days; leg fractures 19% of cases and 33% of all activity restricted days; and other fractures 16% of the cases but only 5% of the activity restricted days in this population. Conclusion—The incidence of fractures increases in childhood. Different types of fractures among children cause different amounts of activity restriction.

A global perspective on the outcomes of surgical decompression in patients with cervical spondylotic myelopathy: results from the prospective multicenter AOSpine international study on 479 patients.

Study Design. Prospective, multicenter international cohort. Objective. To evaluate outcomes of surgical decompression for cervical spondylotic myelopathy (CSM) at a global level. Summary of Background Data. CSM is a degenerative spine disease and the most common cause of spinal cord dysfunction worldwide. Surgery is increasingly recommended as the preferred treatment strategy for CSM to improve neurological and functional status and quality of life. The outcomes of surgical intervention for CSM have never been evaluated at an international level. Methods. Between October 2007 and January 2011, 479 symptomatic patients with image evidence of CSM were enrolled in the prospective, multicenter AOSpine CSM-International study from 16 global sites. Preoperative and postoperative clinical status, functional impairment, and quality of life were evaluated using the modified Japanese Orthopaedic Assessment Scale, Nurick Scale, Neck Disability Index, and Short-Form-36v2. Preoperative and 12- and 24-month postoperative outcomes were compared using mixed-model analysis of covariance for repeated measurements. Results. The study cohort consisted of 310 males and 169 females, with a mean age of 56.37 ± 11.91 years. There were significant differences in age, etiology, and surgical approaches between the regions. At 24 months postoperatively, the mean modified Japanese Orthopaedic Assessment Scale score improved from 12.50 (95% confidence interval [CI], 12.24–12.76) to 14.90 (95% CI, 14.64–15.16); the Neck Disability Index improved from 36.38 (95% CI, 34.33–38.43) to 23.20 (95% CI, 21.24–25.15); and the SF36v2 Physical Component Score and Mental Composite Score improved from 34.28 (95% CI, 33.46–35.10) to 40.76 (95% CI, 39.71–41.81) and 39.45 (95% CI, 38.25–40.64) to 46.24 (95% CI, 44.94–47.55), respectively. The rate of neurological complications was 3.13%. Conclusion. Surgical decompression for CSM is safe and results in improved functional status and quality of life in patients around the world, irrespective of differences in medical systems and sociocultural determinants of health. Level of Evidence: 3