General Session: Cervical-2
Presented by: P. McAfee - View Audio/Video Presentation (Members Only)
P. McAfee(1), L. Chotikul(1), I. Fedder(1), M. Dabbah(1), E. Shucosky(1)
(1) University of Maryland St Joseph Medical Center, Orthopedic Surgery, Towson, MD, United States
Purpose: The current study was undertaken to investigate the peri-operative and radiographic outcomes of a PEEK combined interbody spacer with integral screws for anterior cervical diskectomy and fusion (ACDF). The primary objectives in this prospective study were to compare the survivorship of an Integrated Titanium Plate, PEEK spacer and screws with the last five Control Groups in five consecutive ACDF FDA studies utilizing allograft and anterior cervical plates—Bryan, ProDisk, Prestige, PCM, and Secure C.
Methods: A consecutive series of 238 patients presenting with cervical radiculopathy, myelopathy, or spondylosis underwent ACDF with the integrated plate, PEEK spacer, and screw system. A total of 460 operative levels comprise the basis for the treatment group -- 90 single level, 91 two level, 40 three level and 17 four level ACDF procedures reconstructed using a stand alone PEEK interbody spacer with integral screws. For all cases, the PEEK cages were packed with local autogenous graft. The integrated PEEK spacer patients were much higher risk for pseudarthrosis compared to the FDA Control patients—the treatment group included multilevel cases, elderly patients, osteopenia, cigarette smokers and patients with brittle diabetes, on chronic steroids, and with adjacent cervical fusions. Radiographic criterion for fusion was defined as 2 degrees or less of segmental motion based on flexion-extension plain films.
Results: In the treatment group the mean patient age, EBL, operative time and demographics were similar to the FDA Control Groups. As expected in the Treatment Group the length of stay (days) was dependent on the number of operative levels: single level (1.8±0.5), two level (2.0±1.0), three level (2.5±2.6) and four level (2.8±3.2) (p< 0.05). There were eight levels in the treatment group that required reoperation -secondary surgery rate of reoperation 8 of 460 (1.74%) compared to 61 of 912 levels in the 5 FDA Control Groups (6.69%) (Fisher exact test, p=0.049) (Table 1). There was one additional asymptomatic radiographic pseudoarthrosis level which is currently being followed clinically without plans for revision.
Conclusions: Anterior cervical fusion using a PEEK interbody spacer with integral screws for ACDF demonstrated more favorable two year results than allograft and plate FDA Control Groups with radiographic evidence of fusion observed in 98.0% of patients treated - representing 451/460 operative levels. (1 radiographic pseudarthrosis and eight levels requiring secondary surgery). The non-device related AE were similar. The current study serves as the first clinical investigation of this stand alone interbody fusion device, which provides an alternative to the use of conventional anterior cervical plates for ACDF procedures.