title: The efficacy of lumbar discectomy and single-level fusion for spondylolisthesis: results from the NeuroPoint-SD registry: clinical article.
abstract: OBJECTIVE
  There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures.
  
  
  METHODS
  An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform.
  
  
  RESULTS
  Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work.
  
  
  CONCLUSIONS
  It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).
authors.affiliation: Wallace Trials Center, Greenwich Hospital, Greenwich, Connecticut;
authors.forename: Zoher
authors.initials: Z
authors.lastname: Ghogawala
authors.forename: Christopher I
authors.initials: CI
authors.lastname: Shaffrey
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Asher
authors.forename: Robert F
authors.initials: RF
authors.lastname: Heary
authors.forename: Tanya
authors.initials: T
authors.lastname: Logvinenko
authors.forename: Neil R
authors.initials: NR
authors.lastname: Malhotra
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Dante
authors.forename: R John
authors.initials: RJ
authors.lastname: Hurlbert
authors.forename: Andrea F
authors.initials: AF
authors.lastname: Douglas
authors.forename: Subu N
authors.initials: SN
authors.lastname: Magge
authors.forename: Praveen V
authors.initials: PV
authors.lastname: Mummaneni
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Cheng
authors.forename: Justin S
authors.initials: JS
authors.lastname: Smith
authors.forename: Michael G
authors.initials: MG
authors.lastname: Kaiser
authors.forename: Khalid M
authors.initials: KM
authors.lastname: Abbed
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Sciubba
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Resnick
mesh_terms: D000328:Adult; D000368:Aged; D017586:Diskectomy / Q000009:adverse effects / Q000379:methods / Q000592:standards*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008161:Lumbosacral Region / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012042:Registries / Q000592:standards*; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000009:adverse effects / Q000379:methods / Q000592:standards*; D013168:Spondylolisthesis / Q000601:surgery*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome