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Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.
Ghogawala, Z, Terrin, N, Dunbar, MR, Breeze, JL, Freund, KM, Kanter, AS, Mummaneni, PV, Bisson, EF, Barker, FG, Schwartz, JS, et al
JAMA. 2021;(10):942-951
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Abstract
IMPORTANCE Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. OBJECTIVE To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. INTERVENTIONS Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. MAIN OUTCOMES AND MEASURES The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. RESULTS Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). CONCLUSIONS AND RELEVANCE Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02076113.
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A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders.
Coughlan, M, Davies, M, Mostert, AK, Nanda, D, Willems, PC, Rosenberg, G, Ferch, R
Spine. 2018;(15):E860-E868
Abstract
STUDY DESIGN A prospective, Phase IV, multicenter, randomized study. OBJECTIVE The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine. SUMMARY OF BACKGROUND DATA Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation. METHODS Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. RESULTS One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population. CONCLUSION SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2. LEVEL OF EVIDENCE 2.
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Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2.
Arnold, PM, Anderson, KK, Selim, A, Dryer, RF, Kenneth Burkus, J
Journal of neurosurgery. Spine. 2016;(3):292-302
Abstract
OBJECTIVE Heterotopic ossification (HO) has been reported following total hip, knee, cervical, and lumbar arthroplasty, as well as following posterolateral lumbar fusion using recombinant human bone morphogenetic protein-2 (rhBMP-2). Data regarding HO following anterior cervical discectomy and fusion (ACDF) with rhBMP-2 are sparse. A subanalysis was done of the prospective, multicenter, investigational device exemption trial that compared rhBMP-2 on an absorbable collagen sponge (ACS) versus allograft in ACDF for patients with symptomatic single-level cervical degenerative disc disease. METHODS To assess differences in types of HO observed in the treatment groups and effects of HO on functional and efficacy outcomes, clinical outcomes from previous disc replacement studies were compared between patients who received rhBMP-2/ACS versus allograft. Rate, location, grade, and size of ossifications were assessed preoperatively and at 24 months, and correlated with clinical outcomes. RESULTS Heterotopic ossification was primarily anterior in both groups. Preoperatively in both groups, and including osteophytes in the target regions, HO rates were high at 40.9% and 36.9% for the rhBMP-2/ACS and allograft groups, respectively (p = 0.350). At 24 months, the rate of HO in the rhBMP-2/ACS group was higher than in the allograft group (78.6% vs 59.2%, respectively; p < 0.001). At 24 months, the rate of superior-anterior adjacent-level Park Grade 3 HO was 4.2% in both groups, whereas the rate of Park Grade 2 HO was 19.0% in the rhBMP-2/ACS group compared with 9.8% in the allograft group. At 24 months, the rate of inferior-anterior adjacent-level Park Grade 2/3 HO was 11.9% in the rhBMP-2/ACS group compared with 5.9% in the allograft group. At 24 months, HO rates at the target implant level were similar (p = 0.963). At 24 months, the mean length and anteroposterior diameter of HO were significantly greater in the rhBMP-2/ACS group compared with the allograft group (p = 0.033 and 0.012, respectively). Regarding clinical correlation, at 24 months in both groups, Park Grade 3 HO at superior adjacent-level disc spaces significantly reduced range of motion, more so in the rhBMP-2/ACS group. At 24 months, HO negatively affected Neck Disability Index scores (excluding neck/arm pain scores), neurological status, and overall success in patients in the rhBMP-2/ACS group, but not in patients in the allograft group. CONCLUSIONS Implantation of rhBMP-2/ACS at 1.5 mg/ml with polyetheretherketone spacer and titanium plate is effective in inducing fusion and improving pain and function in patients undergoing ACDF for symptomatic single-level cervical degenerative disc disease. At 24 months, the rate and dimensions (length and anteroposterior diameter) of HO were higher in the rhBMP-2/ACS group. At 24 months, range of motion was reduced, with Park Grade 3 HO in both treatment groups. The impact of Park Grades 2 and 3 HO on Neck Disability Index success, neurological status, and overall success was not consistent among the treatment groups. The study data may offer a deeper understanding of HO after ACDF and may pave the way for improved device designs. Clinical trial registration no.: IDE# G060021; data compared with pooled data from control arms of IDE# G010188/NCT00642876 and IDE# G000123/NCT00437190 ( www.clinicaltrials.gov ).
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The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol.
Kersten, RF, van Gaalen, SM, Arts, MP, Roes, KC, de Gast, A, Corbin, TP, Öner, FC
BMC musculoskeletal disorders. 2014;:57
Abstract
BACKGROUND Polyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. METHODS/DESIGN This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18-75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. DISCUSSION In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders. TRIAL REGISTRATION NCT01557829.
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Bioabsorbable anterior cervical plating: initial multicenter clinical and radiographic experience.
Aryan, HE, Lu, DC, Acosta, FL, Hartl, R, McCormick, PW, Ames, CP
Spine. 2007;(10):1084-8
Abstract
STUDY DESIGN Prospective clinical trial. OBJECTIVE The authors present their initial multicenter experience in the surgical management of 1-level degenerative disc disease of the cervical spine with anterior cervical discectomy and fusions (ACDF) using a bioabsorbable polymer plate. SUMMARY OF BACKGROUND DATA The introduction of a radiolucent bioabsorbable polymer plate and screws for ACDF presents a novel opportunity to gain the some of the potential added benefit of stabilization with internal immobilization while possibly reducing some of the long-term complications and imaging artifacts associated with titanium instrumentation. We prospectively analyze 52 patients who were treated at 6 different institutions across the United States with bioabsorbable polymer plate and screws for ACDF surgery. METHODS Patients were prospectively enrolled. A retrospective review of patients' charts and imaging was performed to determine clinical and radiographic outcome following anterior cervical spine surgery. Specifically, the authors looked at need for additional surgeries, local reaction to bioabsorbable polymer, fusion rate, and complications. Surgeries involved the C4-C5, C5-C6, C6-C7, and/or C7-T1 levels. Cadaveric bone was used in 42 patients, polyetheretherketone (PEEK) cages in 6 patients, and iliac crest autograft in 4 patients. The patients were observed for an average of 13.3 months. RESULTS Radiographic fusion was achieved in 98.1% (51 of 52 patients) of the cases at 6 months. One patient has evidence of nonunion on flexion-extension imaging but remains asymptomatic. A different patient developed mild kyphosis after surgery and had persistence of radicular symptoms but refused further surgery. There were no clinical signs or symptoms of reaction to the bioabsorbable material. CONCLUSIONS The rates of fusion following single-level ACDF with internal fixation using bioabsorbable polymer plate and screws in this study match those previously reported in the literature with metallic implants and are superior to noninstrumented fusions. Preliminary results suggest that this newly available technology for anterior fusion may be as effective as traditional titanium plating systems in single-level disease. The bioabsorbable material appears to be well tolerated by patients. A larger, randomized, controlled study is necessary to bring the results to statistical significance.
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Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion.
Glassman, SD, Dimar, JR, Carreon, LY, Campbell, MJ, Puno, RM, Johnson, JR
Spine. 2005;(15):1694-8
Abstract
STUDY DESIGN Prospective, randomized, unblinded study of iliac crest bone graft (ICBG) versus recombinant human bone morphogenetic protein-2/compression resistant matrix (rhBMP-2/CRM)in a posterolateral instrumented fusion procedure. OBJECTIVES Document initial radiographic characteristics, based on computed tomography, with rhBMP-2/CRM for posterolateral fusion at 6 and 12-month intervals. SUMMARY OF BACKGROUND DATA As the acceptance of INFUSE bone graft as an ICBG replacement becomes more widespread, surgeons have begun to study applications for rhBMP-2 in posterior spinal fusion. Preclinical studies have examined variables including carrier composition, rhBMP-2 concentration, and rhBMP-2 dose. Pilot studies have been performed with encouraging initial results. METHODS Patients with single level lumbar degenerative disease were enrolled in a randomized study of ICBG versus rhBMP-2/CRM in a posterolateral instrumented fusion procedure. Computed tomography scans at 6 and 12 months were graded as demonstrating no fusion (grade 1), partial or limited unilateral fusion (grade 2), partial or limited bilateral fusion (grade 3), solid unilateral fusion (grade 4), or solid bilateral fusion (grade 5). RESULTS At our institution, 74 patients (38 rhBMP-2/CRM, 36 ICBG) reached minimum 1-year follow-up and were included in this analysis. Mean fusion grade (scale1-5) at 6 months after surgery was 4.35 in the rhBMP-2/CRM group versus 3.09 in the ICBG group (P < 0.0001). At 1 year after surgery mean fusion grade was 4.62 in the rhBMP-2/CRM group versus 3.77 in the ICBG group (P < 0.0023). CONCLUSIONS These early results are encouraging and suggest a more rapid incorporation and development of the fusion mass with rhBMP-2/CRM than iliac crest autograft in a single level posterior instrumented fusion.