Background: Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. Design and methods: This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. Ethics and dissemination: This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. Study registration: ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. Level of evidence: 3.

Background: Adjacent-segment disease (ASD) is a well-described long-term complication after lumbar fusion. There is a lack of consensus about the risk factors for development of ASD, but identifying them could improve surgical outcomes. Our goal was to analyze the effect of patient characteristics and radiographic parameters on the development of symptomatic ASD requiring revision surgery after posterior lumbar fusion.Methods: In this retrospective cohort study, we identified patients who underwent lumbar fusion surgery and revision surgery from May 2012 to November 2018 using an institutional lumbar fusion registry. Patients having both pre- and post-operative upright radiographs were included in the study. Revision surgeries for which the index operation was performed at an outside hospital were excluded from analysis. Univariate analysis was conducted on candidate variables, and variables withP< 0.2 were selected for multivariate logistic regression.Results: Of the 106 patients identified, 21 required reoperation (29 months average follow-up). Age >65 years (OR 4.14, 95% CI 1.46–11.76,P= 0.008), body mass index (BMI) >34 (OR 1.13, 95% CI 1.04–1.23,P= 0.004), and osteoporosis (OR 14, 95% CI 1.38–142.42,P= 0.03) were independent predictors of reoperation in the multivariate analysis. Increased facet diastasis at fusion levels (OR 0.60, 95% CI 0.42–0.85,P= 0.004) was associated with reduced reoperation rates. Change in segmental LL at the index operation level, rostral and caudal facet diastasis, vacuum discs, and T2 hyperintensity in the facets were not predictors of reoperation.Conclusion: Age >65, BMI >34, and osteoporosis were independent predictors of adjacent-segment reoperation after lumbar spinal fusion.

The authors report the case of a 14-year-old girl with a residual malignant peripheral nerve sheath tumor after thoracotomy, chemotherapy, and radiation therapy. The residual tumor, which involved the intercostal muscles, aorta, and neural foramina of T4–10, was completely resected through a costotransversectomy and multiple hemilaminotomies with the patient in the prone position and was stabilized using a T1–12 pedicle screw fusion. Postoperatively, the patient developed several infections requiring multiple washouts and prolonged antibiotics. Thirty months after surgery, she developed a bronchocutaneous fistula. The hardware was removed, and a vascularized latissimus dorsi free flap was placed over the lung. She continued to have an air leak and presented 3 weeks later with a 40° left thoracic curve. She returned to the operating room for a T2–L2 fusion with a vascularized fibular graft. On postoperative Day 1, she underwent a bronchoscopy and had her left lower lobe airways occluded with multiple novel...

BACKGROUND AND OBJECTIVES: Return-to-work (RTW) is an important outcome for employed patients considering surgery for cervical spondylotic myelopathy (CSM). We conducted a post hoc analysis of patients as-treated in the Cervical Spondylotic Myelopathy Surgical Trial, a prospective, randomized trial comparing surgical approaches for CSM to evaluate factors associated with RTW. METHODS: In the trial, patients were randomized (2:3) to either anterior surgery (anterior cervical decompression/fusion [ACDF]) or posterior surgery (laminoplasty [LP], or posterior cervical decompression/fusion [PCDF], at surgeon's discretion). Work status was recorded at 1, 3, 6, and 12 months postoperatively. For patients working full-time or part-time on enrollment, time to RTW was compared across as-treated surgical groups using discrete-time survival analysis. Multivariate logistic regression was used to assess predictors of RTW. Clinical outcomes were compared using a linear mixed-effects model. RESULTS: A total of 68 (42%) of 163 patients were working preoperatively and were analyzed. In total, 27 patients underwent ACDF, 29 underwent PCDF, and 12 underwent LP. 45 (66%) of 68 patients returned to work by 12 months. Median time to RTW differed by surgical approach (LP = 1 month, ACDF = 3 months, PCDF = 6 months; P = .02). Patients with longer length-of-stay were less likely to be working at 1 month (odds ratio 0.51; 95% CI, 0.29-0.91; P = .022) and 3 months (odds ratio 0.39; 95% CI, 0.16-0.96; P = .04). At 3 months, PCDF was associated with lower Short-Form 36 physical component summary scores than ACDF (estimated mean difference [EMD]: 6.42; 95% CI, 1.4-11.4; P = .007) and LP (EMD: 7.98; 95% CI, 2.7-13.3; P = .003), and higher Neck Disability Index scores than ACDF (EMD: 12.48; 95% CI, 2.3-22.7; P = .01) and LP (EMD: 15.22; 95% CI, 2.3-28.1; P = .014), indicating worse perceived physical functioning and greater disability, respectively. CONCLUSION: Most employed patients returned to work within 1 year. LP patients resumed employment earliest, while PCDF patients returned to work latest, with greater disability at follow-up, suggesting that choice of surgical intervention may influence occupational outcomes.

Background/Objectives: Spinal fusion surgery is an accepted form of management for select patients who suffer from degenerative lumbar disease. The need for cost-effective durable techniques is paramount as our population ages. This study compares the radiographic and clinical outcomes of PEEK and 3D-printed titanium interbody cages. Methods: This study compared two cohorts which underwent either PEEK or 3D-printed titanium (3DPT) interbody fusion at a single institution between 2013 and 2022. The PEEK cohort was a retrospective analysis of a prospectively collected registry. The 3DPT data were prospectively collected. The inclusion criteria were adults >18 years who underwent 1 or 2 level lumbar interbody fusion for degenerative spine disease with at least 6 months follow-up. Patient demographics, radiographs, and PROMs were collected. The cohorts were compared using ANOVA for continuous variables and Fisher’s exact test for categorical variables, with significance set to 0.05. Results: The final study included 91 patients, 49 PEEK and 42 3DPT. The 3DPT patients were older (p = 0.047) with increased incidence of hypertension (p < 0.001). The 3DPT patients had less bone morphogenetic protein (BMP) usage (80.9% vs. 54.8%; p = 0.012), but more cellular allograft (p < 0.001). Fusion rate was high for both cohorts, with PEEK at 95.9% and 3DPT at 97.6%. There was no significant difference in reoperation rate. Both the PEEK and 3DPT cohorts demonstrated an improvement in the Oswestry Disability Index (ODI) and EuroQol 5 Dimension (EQ-5D) at 1 and 2 years compared to preoperative baseline. More patients in the 3DPT group met the MCID for EQ-5D at 1 and 2 years compared to PEEK; however, this was not significant (p = 0.350; p = 1.000). Conclusions: The 3DPT interbody provided comparable if not superior fusion properties to the PEEK interbody given the decreased use of BMP. Both cohorts demonstrated similar improvements in ODI and EQ-5D compared to preoperative baseline. These results suggest that 3DPT cages may be a cost-effective alternative in spinal fusion. Further studies utilizing a larger population with higher follow-up rates are indicated to determine the economic and clinical benefits of 3DPT compared to PEEK cages in lumbar fusion surgery.