CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
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Comparison of radiographic changes after ACDF versus Bryan disc arthroplasty in single and bi-level cases.

European Spine Journal 2009 Februrary
The object of this study is to compare radiographic outcomes of anterior cervical decompression and fusion (ACDF) versus cervical disc replacement using the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) in terms of range of motion (ROM), Functional spinal unit (FSU), overall sagittal alignment (C2-C7), anterior intervertebral height (AIH), posterior intervertebral height (PIH) and radiographic changes at the implanted and adjacent levels. The study consisted of 105 patients. A total of 63 Bryan disc were placed in 51 patients. A single level procedure was performed in 39 patients and a two-level procedure in the other 12. Fifty-four patients underwent ACDF, 26 single level cases and 28 double level cases. The Bryan group had a mean follow-up 19 months (12-38). Mean follow-up for the ACDF group was 20 months (12-40 months). All patients were evaluated using static and dynamic cervical spine radiographs as well as MR imaging. All patients underwent anterior cervical discectomy followed by autogenous bone graft with plate (or implantation of a cage) or the Bryan artificial disc prosthesis. Clinical evaluation included the visual analogue scale (VAS), and neck disability index (NDI). Radiographic evaluation included static and dynamic flexion-extension radiographs using the computer software (Infinitt PiviewSTAR 5051) program. ROM, disc space angle, intervertebral height were measured at the operative site and adjacent levels. FSU and overall sagittal alignment (C2-C7) were also measured pre-operatively, postoperatively and at final follow-up. Radiological change was analyzed using chi(2) test (95% confidence interval). Other data were analyzed using the mixed model (SAS enterprises guide 4.1 versions). There was clinical improvement within each group in terms of VAS and NDI scores from pre-op to final follow-up but not significantly between the two groups for both single (VAS p=0.8371, NDI p=0.2872) and double (VAS p=0.2938, NDI p=0.6753) level surgeries. Overall, ROM and intervertebral height was relatively well maintained during the follow-up in the Bryan group compared to ACDF. Regardless of the number of levels operated on, significant differences were noted for overall ROM of the cervical spine (p<0.0001) and all other levels except at the upper adjacent level for single level surgeries (p=0.2872). Statistically significant (p<0.0001 and p=0.0172) differences in the trend of intervertebral height measurements between the two groups were noted at all levels except for the AIH of single level surgeries at the upper (p=0.1264) and lower (p=0.7598) adjacent levels as well as PIH for double level surgeries at the upper (p=0.8363) adjacent level. Radiological change was 3.5 times more observed for the ACDF group. Clinical status of both groups, regardless of the number of levels, showed improvement. Although clinical outcomes between the two groups were not significantly different at final follow-up, radiographic parameters, namely ROM and intervertebral heights at the operated site, some adjacent levels as well as FSU and overall sagittal alignment of the cervical spine were relatively well maintained in Bryan group compared to ACDF group. We surmise that to a certain degree, the maintenance of these parameters could contribute to reduce development of adjacent level change. Noteworthy is that radiographic change was 3.5 times more observed for ACDF surgeries. A longer period of evaluation is needed, to see if all these radiographic changes will translate to symptomatic adjacent level disease.

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