Prospective, multi-institutional surgical data collection in pediatric neuro-oncology remains limited despite substantial variation in operative and perioperative management across institutions. To address this, we are developing the NeuroPoint Alliance (NPA) Quality Outcomes Database (QOD) Pediatric Tumor Surgery Registry. Here, we used a modified Delphi process to define a core outcome set for the registry. A modified Delphi study was conducted among pediatric neurosurgeons serving as site principal investigators for the proposed registry. Candidate data elements were rated on a 9-point Likert scale. Consensus for inclusion was predefined as ≥70
BACKGROUND:In children with Chiari type I malformation and syringomyelia, neurosurgical posterior fossa decompression (PFD) provides clinical improvement, but whether duraplasty (incising the dura and placing a dural graft) improves outcomes is unclear. METHODS:We conducted a multicenter, cluster-randomized, controlled trial of PFD with duraplasty (PFD-D) as compared with PFD alone. Persons 21 years of age or younger with cerebellar tonsillar ectopia of at least 5 mm and a maximum syrinx diameter of 3.0 to 9.9 mm were enrolled at 38 centers. Centers were cluster-randomized: all the participants within each center underwent the same intervention. The primary outcome was surgical complications within 6 months. Secondary outcomes were clinical improvement, syrinx reduction, and repeat decompression at 10 to 24 months and the change in overall health-related quality of life at 6 to 24 months. RESULTS:A total of 162 participants were included in the trial, of whom 78 were assigned to undergo PFD-D and 84 to undergo PFD alone. The percentage of participants with complications within 6 months was 14% with PFD-D and 6% with PFD (adjusted odds ratio, 2.59; 95% confidence interval [CI], 0.86 to 7.84; P = 0.11). At 24 months, the percentage of participants with clinical improvement was 58% with PFD-D and 46% with PFD; the mean (±SD) syrinx reduction was 3.08±2.33 mm and 1.22±1.79 mm, respectively; and the percentage of participants with repeat decompression was 3% and 14%. Changes in health-related quality of life were similar in the two groups. CONCLUSIONS:The percentage of participants with surgical complications did not differ significantly between those who underwent PFD-D and and those who underwent PFD alone. Larger trials are needed to determine the relative benefits and risks of these two procedures. (Funded by the Patient-Centered Outcomes Research Institute and others; ClinicalTrials.gov number, NCT02669836.).
STUDY DESIGN:Retrospective review. OBJECTIVE:Determine the rate of bony union of an integrated cage/screw polyether-ethyl ketone (PEEK) cervical interbody fusion device with computed tomography (CT) and provide long-term outcomes of patients treated with such. SUMMARY OF BACKGROUND DATA:Anterior cervical discectomy and fusion (ACDF) is a common treatment option for patients with degenerative cervical conditions that have failed conservative treatment. Stand-alone anchored cages offer the theoretical advantage of decreasing soft tissue dissection off the anterior vertebral body and mitigating risk to surrounding structures while still achieving solid fusion. METHODS:A retrospective review was conducted from a single institution's enrollment data during a postmarket surveillance study for the Stalif-C (Centinel Spine, West Chester, PA). Three surgeons independently reviewed CT scans from 1 and 2-year follow-up visits to assess for fusion. The criteria for fusion were the presence of bridging bone in at least one of 5 regions (anterior, posterior, right, left uncovertebral joint, and intracage) on 2 consecutive slices of the CT scan using 1 mm coronal and sagittal reformats. These same surgeons repeated their assessment of the imaging studies at a minimum of 2 weeks after the initial review. The resulting fusion rates were then averaged to provide a mean fusion rate at the 1 and 2-year points. RESULTS:A total of 34 patients were enrolled in the study with 2 patients withdrawing consent after the procedure. Thirty had completed their 1-year follow-up with imaging studies comprising 32 levels treated. Twenty-three patients (25 levels) completed a 2-year follow-up at the time of this study. The average bony fusion rate at 1 year was 37% (range: 19%-56%) and at 2 years was 50% (range: 40%-60%). CONCLUSION:The rate of bony fusion as assessed by CT scans at 1 and 2 years was 37% and 50%, respectively. This is well below previously published fusion rates for standalone constructs. LEVEL OF EVIDENCE:Level III.
STUDY DESIGN:Prospective, nonrandomized cohort analysis. OBJECTIVE:To evaluate five-year outcomes of patients treated with a polyetheretherketone (PEEK)-on-ceramic cTDR device at two levels for radiculopathy and/or myelopathy. BACKGROUND:Cervical total disc replacement (cTDR) has gained acceptance as a treatment for symptomatic cervical degenerative disc disease (DDD). Long-term follow-up studies are required to further assess clinical and radiographic outcomes, specifically for patients treated at two consecutive levels. METHODS:Patients implanted with Simplify Cervical Disc at two levels from C3 to 7 as part of a Food and Drug Administration investigational device exemption trial (NCT03123549) were contacted, consented, and prospectively followed from 36 to 60 months. RESULTS:Of 181 patients treated, 80% (144) completed five-year follow-up. Composite clinical success was 86% at 60 months versus 88% at 24 months. At 60 months, 95% had a minimum 15-point improvement in Neck Disability Index compared with 93% at 24 months. Mean neck pain improvement at 24 months (-6.1 on a 10-point numeric scale) was maintained at 60 months. Similarly, improvements in arm pain scores were also maintained from -5.7 at 24 months to -6.2 at 60 months. The cumulative five-year index level reoperation rate was 5% (1%/year) and the adjacent level reoperation rate was 2.2% (0.4%/year). Segmental range of motion was maintained at both operated segments through five years, with an average of 9.0° at superior and 8.7° at inferior levels. Bridging bone was identified in 1% of both the superior and inferior levels, 6% of superior levels only, and 6% of inferior levels only. CONCLUSIONS:This intermediate five-year follow-up study augments previously reported two-year results, supporting that the Simplify cTDR is safe and effective for the treatment of two-level symptomatic cervical DDD. Statistically significant improvements in pain and disability at two-year postoperative were maintained or improved at five years with preservation of motion and low reoperation rates at index and adjacent levels.
