Journal of neurosurgery. Spine
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Multicenter Study Clinical Trial
Prospective assessment of the safety and early outcomes of sublaminar band placement for the prevention of proximal junctional kyphosis.
OBJECTIVE Proximal junctional kyphosis (PJK) can progress to proximal junctional failure (PJF), a widely recognized early and serious complication of multisegment spinal instrumentation for the treatment of adult spinal deformity (ASD). Sublaminar band placement has been suggested as a possible technique to prevent PJK and PJF but carries the theoretical possibility of a paradoxical increase in these complications as a result of the required muscle dissection and posterior ligamentous disruption. In this study, the authors prospectively assess the safety as well as the early clinical and radiological outcomes of sublaminar band insertion at the upper instrumented vertebra (UIV) plus 1 level (UIV+1). ⋯ Moreover, no subjects developed PJF. Prospective large-scale and long-term analysis is needed to define the potential benefit of sublaminar bands in reducing the incidence of PJK and PJF following surgery for ASD. Clinical trial registration no.: NCT02411799 (clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study Comparative Study
Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization.
OBJECTIVE Surgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS. ⋯ The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure. Clinical trial registration no.: NCT01316211 (clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study Comparative Study
Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.
OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. ⋯ CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study
Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial.
OBJECTIVE Structured physiotherapy has been suggested as treatment before as well as after surgery to improve clinical outcomes in patients with cervical radiculopathy (CR), but randomized clinical trials to inform evidence-based clinical guidelines for the treatment of patients with CR after surgery are lacking. The aim of this study was to compare the results of structured postoperative physiotherapy combining neck-specific exercises with a behavioral approach to a standard postoperative approach in patients who had undergone surgery for cervical disc disease with CR at 6 months after surgery. METHODS Patients with cervical disc disease and persistent CR who were scheduled for surgery were randomized preoperatively to structured postoperative physiotherapy (n = 101) or a standard postoperative approach (n = 100). ⋯ Patients who received structured postoperative physiotherapy reported higher expectation fulfillment, and many patients in the standard postoperative approach group perceived a need for additional treatments after surgery, suggesting that patients with CR are in need of further postoperative support. The results confirm that neck-specific exercises are tolerated postoperatively by patients with CR, but more studies of postoperative physiotherapy are needed to inform clinical guidelines for this patient group. Clinical trial registration no.: NCT01547611 (clinicaltrials.gov).
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OBJECTIVE Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database. METHODS This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ⋯ The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.