Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion.

BACKGROUND: Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success. OBJECTIVE: To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study. METHODS: Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control). RESULTS: The study met statistical noninferiority success for all 4 coprimary end points. Radiographic fusion was achieved in 99% (103/104) and 98.2% (109/111) in i-FACTOR and local autograft subjects, mean Neck Disability Index improvement from baseline was 28.6 (24.8, 32.3) in the i-FACTOR and 29.2 (25.6, 32.9) in the control group, respectively (noninferiority P < .0001). The neurological success rate at 6 years was 95.9% (70/73) in i-FACTOR subjects and 93.7% (70/75) in local autograft subjects (noninferiority P < .0001). Safety outcomes were similar between the 2 groups. Secondary surgery on the same or different cervical levels occurred in 20/106 (18.9%) i-FACTOR subjects and 23/114 (20.2%) local autograft subjects ( P = .866). Secondary outcomes (pain, SF-36 physical component score and mental component score) in i-FACTOR subjects were similar to those in local autograft subjects. CONCLUSION: i-FACTOR met all 4 FDA-mandated noninferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion for cervical radiculopathy through 6 years postoperatively. Safety outcomes are acceptable, and the clinical and functional outcomes observed at 12 and 24 months remained at 72 months.

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. METHODS: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. RESULTS: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. CONCLUSIONS: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.

Improving blood product utilization at an ambulatory surgery center: a retrospective cohort study on 50 patients with lumbar disc replacement.

BACKGROUND: There is minimal literature discussing anterior lumbar spine surgery in ambulatory surgery centers (ASCs). The main concern with the anterior approach to the lumbar spine is the potential for injury to great vessels. In our facility, there are two units of crossmatched blood available in addition to cell saver during the procedure. We retrospectively looked at 50 cases of lumbar total disc arthroplasty (TDA) in our ASC to determine utilization of blood products. METHODS: Medical records of 50 consecutive patients who underwent a lumbar TDA at a single ASC were reviewed. Surgeries completed at the ASC were all transferred from the post anesthesia care unit to an attached convalescence care center which allows up to 3 days of observation. Patients who had either a 1 or 2 level lumbar TDA were included in the study. Data consisting of demographics, American Society of Anesthesiologist Physical Status Classification System, length of stay, estimated blood loss, cell saver volume, transfusion, perioperative and postoperative complications were recorded. Preoperative, perioperative and postoperative medical records were reviewed. RESULTS: Medical records of 50 consecutive patients were reviewed. The mean age was 40.86 ± 9.45. Of these, 48 (96%) had a 1-level lumbar TDA, 1(2%) had a 2-level lumbar TDA, 1 (2%) had a lumbar TDA at L4/5 and an anterior lumbar interbody fusion at L5/S1. There were no mortalities; no patient had recorded perioperative complications. No patients received allogeneic blood transfusion, 4 (8%) were re-transfused with cell saver (2 receiving approximately 400 ml and 2 receiving approximately 200 ml of re-transfused blood). All 50 (100%) were discharged home in stable condition. We had 30-day follow-up data on 35 of 50 patients. Of the 35 patients reviewed, three (8.5%) of the patients were readmitted to the hospital. One additional patient was seen in the emergency department and discharged home after negative testing. No patient was readmitted for post-operative anemia. CONCLUSION: The routine use of both cell saver and crossmatched blood in the operating suite for lumbar TDA may be an over-utilization of healthcare resources. In our review of 50 patients, we had no need for transfusion of allogeneic packed red blood cells (PRBCs) and only four of the 50 patients had enough blood output for re-transfusion from the cell saver. This opens the conversation for alternatives to crossmatched PRBCs being held in the operating room. Such alternatives may be the use of cell salvage, only type O blood in a cooler for each patient or keeping type O blood on constant hold in ASCs.

i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study.

BACKGROUND: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE: To report 2-yr follow-up. METHODS: Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS: At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION: Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.

Geographic variations in clinical presentation and outcomes of decompressive surgery in patients with symptomatic degenerative cervical myelopathy: analysis of a prospective, international multicenter cohort study of 757 patients.

BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness. PURPOSE: The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions. STUDY DESIGN/SETTING: This is a multicenter international prospective cohort study. PATIENT SAMPLE: This study includes a total of 757 symptomatic patients with DCM undergoing surgical decompression of the cervical spine. OUTCOME MEASURES: The outcome measures are the Neck Disability Index (NDI), the Short Form 36 version 2 (SF-36v2), the modified Japanese Orthopaedic Association (mJOA) scale, and the Nurick grade. MATERIALS AND METHODS: The baseline characteristics, disease causation, surgical approaches, and outcomes at 12 and 24 months were compared among four regions: Europe, Asia Pacific, Latin America, and North America. RESULTS: Patients from Europe and North America were, on average, older than those from Latin America and Asia Pacific (p=.0055). Patients from Latin America had a significantly longer duration of symptoms than those from the other three regions (p<.0001). The most frequent causes of myelopathy were spondylosis and disc herniation. Ossification of the posterior longitudinal ligament was most prevalent in Asia Pacific (35.33%) and in Europe (31.75%), and hypertrophy of the ligamentum flavum was most prevalent in Latin America (61.25%). Surgical approaches varied by region; the majority of cases in Europe (71.43%), Asia Pacific (60.67%), and North America (59.10%) were managed anteriorly, whereas the posterior approach was more common in Latin America (66.25%). At the 24-month follow-up, patients from North America and Asia Pacific exhibited greater improvements in mJOA and Nurick scores than those from Europe and Latin America. Patients from Asia Pacific and Latin America demonstrated the most improvement on the NDI and SF-36v2 PCS. The longest duration of hospital stay was in Asia Pacific (14.16 days), and the highest rate of complications (34.9%) was reported in Europe. CONCLUSIONS: Regional differences in demographics, causation, and surgical approaches are significant for patients with DCM. Despite these variations, surgical decompression for DCM appears effective in all regions. Observed differences in the extent of postoperative improvements among the regions should encourage the standardization of care across centers and the development of international guidelines for the management of DCM.

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies.

STUDY DESIGN: A narrative review of literature. OBJECTIVE: This manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature. SUMMARY OF BACKGROUND DATA: Ever since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives. An understanding of the available fusion options and an organized evidence-based approach to their use in spine surgery is essential for achieving optimal results. METHODS: A Medline search of English language literature published through March 2016 discussing bone graft substitutes and fusion extenders was performed. All clinical studies reporting radiological and/or patient outcomes following the use of bone substitutes were reviewed under the broad categories of Allografts, Demineralized Bone Matrices (DBM), Ceramics, Bone Morphogenic proteins (BMPs), Autologous growth factors (AGFs), Stem cell products and Synthetic Peptides. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures viz. trauma, infection or tumors; wherever data was forthcoming. Studies in animal populations and experimental in vitro studies were excluded. Primary endpoints were radiological fusion rates and successful clinical outcomes. RESULTS: A total of 181 clinical studies were found suitable to be included in the review. More than a third of the published articles (62 studies, 34.25%) focused on BMP. Ceramics (40 studies) and Allografts (39 studies) were the other two highly published groups of bone substitutes. Highest radiographic fusion rates were observed with BMPs, followed by allograft and DBM. There were no significant differences in the reported clinical outcomes across all classes of bone substitutes. CONCLUSIONS: There is a clear publication bias in the literature, mostly favoring BMP. Based on the available data, BMP is however associated with the highest radiographic fusion rate. Allograft is also very well corroborated in the literature. The use of DBM as a bone expander to augment autograft is supported, especially in the lumbar spine. Ceramics are also utilized as bone graft extenders and results are generally supportive, although limited. The use of autologous growth factors is not substantiated at this time. Cell matrix or stem cell-based products and the synthetic peptides have inadequate data. More comparative studies are needed to evaluate the efficacy of bone graft substitutes overall.

Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study.

STUDY DESIGN: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. OBJECTIVE: The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA: i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. METHODS: Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months. RESULTS: At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups). CONCLUSION: i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates. LEVEL OF EVIDENCE: 1.

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.

BACKGROUND: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. METHODS: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).

BACKGROUND CONTEXT: Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process, including extent of spinal cord compression, duration of symptoms, and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems, including the central and peripheral nervous systems. There has been little information regarding the effect of diabetes on patients with coexistent CSM. PURPOSE: To provide empirical data regarding the effect of diabetes on treatment outcomes in patients who underwent surgical decompression for coexistent CSM. STUDY DESIGN/SETTING: Large prospective multicenter cohort study of patients with and without diabetes who underwent decompressive surgery for CSM. PATIENT SAMPLE: Two hundred thirty-six patients without and 42 patients with diabetes were enrolled. Of these, 37 were mild cases and five were moderate cases. Four required insulin. There were no severe cases associated with end-organ damage. OUTCOME MEASURES: Self-report measures include Neck Disability Index and version 2 of 36-Item Short Form Health Survey (SF-36v2), and functional measures include modified Japanese Orthopedic Association (mJOA) score and Nurick grade. METHODS: We compared presurgery symptoms and treatment outcomes between patients with and without diabetes using univariate and multivariate models, adjusting for demographics and comorbidities. RESULTS: Diabetic patients were older, less likely to smoke, and more likely to be on social security disability insurance. Patients with diabetes presented with a worse Nurick grade, but there were no differences in mJOA and SF-36v2 at presentation. Overall, there was a significant improvement in all outcome parameters at 12 and 24 months. There was no difference in the level of improvement between the patients with and without diabetes, except in the SF-36v2 Physical Functioning, in which diabetic patients experienced significantly less improvement. There were no differences in surgical complication rates between diabetic patients and nondiabetic patients. CONCLUSIONS: Except for a worse Nurick grade, diabetes does not seem to affect severity of symptoms at presentation for surgery. More importantly, with the exception of the SF-36v2 Physical Functioning scores, outcomes of surgical treatment are similar in patients with diabetes and without diabetes. Surgical decompression is effective and should be offered to patients with diabetes who have symptomatic CSM and are appropriate surgical candidates.

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.

Incidence of dysphagia comparing cervical arthroplasty and ACDF.

STUDY DESIGN: Retrospective cohort from randomized prospective clinical trial. OBJECTIVE: Evaluate incidence of dysphagia between instrumented ACDF and a no-profile cervical disc arthroplasty. SUMMARY OF BACKGROUND DATA: Dysphagia is a well-known complication following anterior cervical discectomy and fusion (ACDF) and the etiology is multifactorial. One potential source for postoperative dysphagia involves the anterior profile of the implant used. Hence, a no-profile cervical disc arthroplasty could theoretically have fewer soft tissue adhesions and a lower incidence of dysphagia. The purpose of this study is to compare the incidence of dysphagia at least 1 year postoperatively following ACDF with anterior plating and a no-profile cervical disc arthroplasty. METHODS: A cohort of 87 patients meeting the inclusion criteria for the prospective, randomized, multicenter IDE trial of ProDisc-C versus ACDF were evaluated for dysphagia. Forty-five patients were randomized to receive cervical arthroplasty and 42 patients were randomized to the ACDF and plate group. The Bazaz-Yoo dysphagia questionnaire was administered in a blinded fashion after completion of at least 12 months follow-up. RESULTS: Follow-up averaged 18.2 months and included 76 (87%) of the 87 enrolled, with 38 of the original 45 in the arthroplasty group and 38 of the original 42 in the ACDF group. Six of 38 (15.8%) in the arthroplasty group versus 16 of 38 (42.1%) in the ACDF group reported ongoing dysphagia complaints. This was found to be statistically significant (P = .03). CONCLUSION: This study suggests a significantly lower rate of dysphagia with a no-profile cervical disc arthroplasty compared to instrumented ACDF for single level disc disease between C3-7. Though there are many potential etiologies, we hypothesize this is related to the lack of anterior hardware in the retropharyngeal space. Operative technique, operating time, and significant midline retraction did not seem to result in more dysphagia complaints. Future studies comparing cervical disc arthroplasty and no-profile fusion devices may help delineate the effect that anterior instrumentation profile has on postoperative dysphagia.

Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients.

BACKGROUND: Cervical total disk replacement (TDR) is intended to address pain and preserve motion between vertebral bodies in patients with symptomatic cervical disk disease. Two-year follow-up for the ProDisc-C (Synthes USA Products, LLC, West Chester, Pennsylvania) TDR clinical trial showed non-inferiority versus anterior cervical discectomy and fusion (ACDF), showing superiority in many clinical outcomes. We present the 4-year interim follow-up results. METHODS: Patients were randomized (1:1) to ProDisc-C (PDC-R) or ACDF. Patients were assessed preoperatively, and postoperatively at 6 weeks and 3, 6, 12, 18, 24, 36, and 48 months. After the randomized portion, continued access (CA) patients also underwent ProDisc-C implantation, with follow-up visits up to 24 months. Evaluations included Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain/satisfaction, and radiographic and physical/neurologic examinations. RESULTS: Randomized patients (103 PDC-R and 106 ACDF) and 136 CA patients were treated at 13 sites. VAS pain and NDI score improvements from baseline were significant for all patients (P < .0001) but did not differ among groups. VAS satisfaction was higher at all time points for PDC-R versus ACDF patients (P = .0499 at 48 months). The percentage of patients who responded yes to surgery again was 85.6% at 24 months and 88.9% at 48 months in the PDC-R group, 80.9% at 24 months and 81.0% at 48 months in the ACDF group, and 86.3% at 24 months in the CA group. Five PDC-R patients (48 months) and no CA patients (24 months) had index-level bridging bone. By 48 months, approximately 4-fold more ACDF patients required secondary surgery (3 of 103 PDC-R patients [2.9%] vs 12 of 106 ACDF patients [11.3%], P = .0292). Of these, 6 ACDF patients (5.6%) required procedures at adjacent levels. Three CA patients required secondary procedures (24 months). CONCLUSIONS: Our 4-year data support that ProDisc-C TDR and ACDF are viable surgical options for symptomatic cervical disk disease. Although ACDF patients may be at higher risk for additional surgical intervention, patients in both groups show good clinical results at longer-term follow-up.

Two-Year Results of a Randomized Controlled Clinical Trial Comparing ProDisc-C and Anterior Cervical Discectomy and Fusion.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) is a well-accepted procedure for the treatment of cervical radiculopathy. Hilibrand et al. reported that adjacent segment disease is known to occur at a rate of 2.9% per year after cervical fusion. Developers of cervical disc replacements postulate that maintaining more normal motion may reduce the rate of adjacent segment disease. The purpose of this study was to compare the 2-year efficacy and safety of ACDF and cervical total disc replacement surgery. METHODS: Eighty-seven patients from 2 sites of this 13 multicenter trial were randomized to treatment with either ACDF or cervical disc replacement surgery with the ProDisc-C (Synthes, Inc., West Chester, Pennsylvania) implant. Patient outcomes were assessed via neck disability index (NDI), visual analog pain scale (VAS), and health survey SF-36 (QualityMetric, Lincoln, Rhode Island). Forty-three patients were treated with ACDF using allograft and plating, and 44 were treated with cervical disc replacement. The average age was 44 (23 to 61) years. All surgical procedures were single level. RESULTS: At all measured time points, both groups showed statistically significant improvement over their preoperative baseline with regard to NDI, VAS arm and neck pain levels, SF-36 mental composite score (MCS), and physical composite score (PCS) (P < .05). At 24 months, the disc replacement group showed results equivalent to the ACDF group with regard to NDI, VAS arm and neck pain, and SF-36 MCS. At 24 months, the disc replacement group showed significantly greater improvement in SF- 36 PCS as compared to the ACDF group (P = .0359). Of note, there was a trend toward greater patient satisfaction in the disc replacement group as compared to the ACDF group (83% versus 71%, P = .144). CONCLUSIONS: This study indicates that the tested disc replacement device achieves 2-year results ranging from equivalent to superior in comparison to ACDF in the treatment of symptomatic cervical disc disease. Long-term maintenance of these results has not yet been determined.

Sagittal split fractures in multilevel cervical arthroplasty using a keeled prosthesis.

This is a case report of intraoperative sagittal split fractures in multilevel cervical disc replacement using a keeled prosthesis. The patient's clinical course is discussed and outcomes measured with the SF-36 questionnaire, oswestry disability index, and visual analog scale neck pain are compared with the other patients at our institution that have undergone multilevel disc replacement. The patient did well and has not had any complications related to the device used or fractures. The risks and techniques to avoid this complication when using a keeled prosthesis are discussed in detail.

The use of computed tomography angiography to define the prevertebral vascular anatomy prior to anterior lumbar procedures.

STUDY DESIGN: Prospective cohort. OBJECTIVE: To determine the efficacy of a single-slice computed tomography (CT) angiogram to define the prevertebral anatomy in patients undergoing an anterior lumbar spine procedure. SUMMARY OF BACKGROUND DATA: Preoperative planning with precise prevertebral anatomic details can help in mini-open anterior lumbar approaches. METHODS: A total of 76 consecutive patients undergoing a minimal incision approach for anterior lumbar surgery were evaluated before surgery with CT angiography. The prevertebral anatomy was documented, and the patients were observed during treatment. RESULTS: There were no complications related to CT angiography. This study directly influenced surgical decision making and the treatment options in 21% of patients. The vena caval confluence limited access to the L5-S1 disc in 3% of patients and at the L4-L5 disc in 92% of the patients. Prevertebral anatomic anomalies were found in 11.8% of patients. Atherosclerotic disease was discovered in 17% of the patients. The major complication rate was 7.5%. CT angiography correlated with intraoperative vascular anatomy in all cases. CONCLUSION: Preoperative CT angiography before anterior approaches was determined to be effective in evaluating the prevertebral vascular anatomy.