Abstract

Introduction:  Anterior Cervical Corpectomy and Fusion (ACCF) procedures are increasing as the population ages and cancer treatments improve.  Currently, one expandable and one non-expandable cervical Vertebral Body Replacement (VBR) devices have been FDA 510(k) approved.  Cervical VBR device specific data has yet to be established.

Object:  To present the efficacy and safety data of the first non-expandable cervical VBR device to receive FDA 510(k) approval.

Methods: A retrospective consecutive series of 56 female and 41 male ACCF patients, from a single institution, were followed for an average of 30 months.   ACCF patients were, on average, taking 11 different daily medications, 40 (41%) were smokers and 39 (40%) were on anticoagulation therapy that required pre- and post-operation management. Eighty-nine percent were American Society of Anesthesiologists (ASA) class III or IV.  Sixty-six patients had pre-operative C2-7 Cobb angles of five degrees or less.  Fusion was determined by CT scan, flexion/extension X-rays or both.  Complications of dysphagia, subsidence, non-union and additional surgery were recorded.  Demographic pre-operative patient characteristics and post-operative fusion rates were presented with descriptive statistics.  Complication rates were tabulated during the follow-up period.

Results:  Fusion was documented in 89 of 93 patients (96%).  To be statistically conservative, the three patients with inadequate radiographic follow-up were counted as non-unions.  Twenty-three patients (25%) had additional surgery during the follow-up period, 5 (5%) planned, 18 (19%) unplanned.

Conclusion:  The fusion rate was 96% and consistent with previous ACCF reports.  Three cases of C-VBR subsidence resulted in dysphagia and subsequent anterior plate removal.  Incidentally, the ACCF rate was noted to be higher than the ACDF rate in this cohort of patients at high risk for surgical morbidity and mortality.  The C-VBR was found to be a safe and effective device for ACCF surgery.