title: Utilization trends of cervical artificial disc replacement during the FDA investigational device exemption clinical trials compared to anterior cervical fusion.
abstract: While anterior cervical discectomy and fusion (ACDF) is the gold standard surgical treatment for cervical disc disease, concerns regarding adjacent segment degeneration lead to the development of cervical disc arthroplasty (CDA). This study compares the utilization trends of CDA versus ACDF during the period of the Food and Drug Administration Investigational Device Exemption clinical trials from 2004 to 2007. The Healthcare Cost and Utilization Project Nationwide Inpatient Sample database was used to identify CDA and ACDF procedures performed in the USA between 2004 and 2007. The prevalence of CDA and ACDF procedures was estimated and stratified by age, sex, diagnosis, census region, payor class, and hospital characteristics. The average length of hospital stay, total charges, and costs were also estimated. The number of CDA surgeries significantly increased annually from 2004 to 2007 and mostly took place at urban non-teaching hospitals. There were no regional differences between CDA and ACDF utilization. There was no difference between sex or admission type between CDA and ACDF patients. ACDF patients were older and had more diabetes, hypertension, and chronic obstructive pulmonary disease. CDA patients were more likely to be discharged home and had shorter hospital stays but had a higher rate of deep venous thrombosis than ACDF patients. Significantly more CDA patients had private insurance while more ACDF patients had Medicare. The average cost was higher for ACDF than CDA. While ACDF dominated surgical intervention for cervical disc disease during the trial period, CDA utilization increased at a significantly greater rate suggesting rapid early adoption.
authors: Department of Orthopaedic Surgery, Mount Sinai Medical Center, 5 East 98 Street, 9th Floor, NY 10029, USA. Electronic address: sheeraz.qureshi@mountsinai.org.
authors: Sheeraz A
authors: SA
authors: Qureshi
authors: Steven M
authors: SM
authors: Koehler
authors: Young
authors: Y
authors: Lu
authors: Samuel
authors: S
authors: Cho
authors: Andrew C
authors: AC
authors: Hecht
mesh_terms: D002574:Cervical Vertebrae / Q000601:surgery*; D002986:Clinical Trials as Topic; D017586:Diskectomy / Q000379:methods*; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants / Q000706:statistics & numerical data*; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D059145:Total Disc Replacement; D014481:United States; D014486:United States Food and Drug Administration
keywords: Anterior cervical discectomy and fusion; Cervical disc arthroplasty; Clinical trials; Cost; Demographics; Nationwide inpatient survey