Comparison of total disc arthroplasty and fusion in treatment of lumbar disc disease: A cohort study protocol

BACKGROUND: In recent years, the clinical efficacy of spinal fusion (SF) or total disc arthroplasty (TDA) in the treatment of the degenerative lumbar disc disease is still controversial. The objective of this retrospective clinical trial was to investigate whether TDA was superior to the SF in the complication rates and clinical outcome scores. METHODS: This retrospective research was based on the Strengthening the Reporting of Observational studies in Epidemiology checklist. Internal clinical data sets for 2014 to 2018 were acquired and consolidated with the approval of the Institutional Review Committee of Shaoxing Hospital of Zhejiang University. Inclusion criteria in this present research included: low back pain without or with the leg pain for more than one year; failure of conservative treatment planned for more than three months; age was 25 to 60 years old; followed up for at least one year. The main outcome measure was disability and pain measured via the Norwegian version of Oswestry disability index 2.0. The other clinical outcomes included Short-Form Health Survey, reoperations, duration of surgery, complications, hospital stay length, as well as the blood loss. The significance was set at 0.05 level with the confidence intervals of 95%. The software package of SPSS (version 21.0; SPSS Inc, Chicago, IL, USA) was applied for all the analyses of statistics. RESULTS: The null hypothesis is that there is no significant difference in outcomes between TDA and SF in the treatment of degenerative lumbar disc disease. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5847).