Study Name |
Summary of Significant Findings (Adverse Events, Complications and Secondary Surgeries) |
Zhang et al., 2012 [12] |
1 BRYAN patient and 4 Fusion patients had reoperations. Heterotopic ossification occurred in 12.5% of CDA patients. |
Cheng et al., 2011 [13] |
Significantly less postoperative dysphagia in BRYAN patients. No secondary surgeries in either treatment groups.
1 spontaneous fusion, 1 deep vein thrombosis and 1 heterotopic ossification in BRYAN group. Three cases of pseudarthrosis in ACDF group. |
Sasso et al., 2011 [14] |
No significant differences in rate of adverse events (grade 3 or 4 WHO), secondary surgeries, adjacent level surgeries between the two treatment groups. |
Coric et al., 2011 [18] |
Rate of dysphagia was higher in ACDF than Kineflex|C. The incidence of index-level and adjacent levels reoperations was similar between the two groups. |
McAfee et al., 2010 [20] |
The rate of dysphagia, assessed by the Bazaz dysphagia questionnaire was significantly higher in fusion patients relative to PCM patients. |
Burkus et al., 2010 [16] |
Similar rates of postoperative dysphagia between the two groups. Rates of revision procedures, supplemental fixation (with and without bone graft stimulator) were significantly lower in the PRESTIGE group. Rate of adjacent level procedures are similar between the two groups. |
Zigler and Delamarter, 2012 [19] |
Rate of implant-related and surgery-related adverse events are similar between the two groups. At 5 years, the rate of secondary surgery for ProDisc-C patients was significantly lower than that for ACDF patients. More patients in the ACDF group had reoperations involving adjacent level(s) than ProDisc-C patients. (No statistics were provided) |
Porchet et al., 2004 [15] |
19 adverse events in ACDF patients and 17 adverse events in PRESTIGE patients. Most of these events resolved with rest or therapy. |