Surgical Outcomes of Anterior Cervical Fusion Using Deminaralized Bone Matrix as Stand-Alone Graft Material: Single Arm, Pilot Study.

Abstract

ObjectiveTo investigate the safety and efficacy of demineralized bone matrix (DBM) as a bone graft substitute for anterior cervical discectomy and fusion (ACDF) surgery.MethodsTwenty consecutive patients treated with ACDF using stand-alone polyestheretherketone (PEEK) cages (Zero-P) with DBM(CGDBM100) were prospectively evaluated with a minimum of 6 months of follow-up. Radiologic efficacy was evaluated with a 6-point scoring method for osseous fusion using plain radiograph and computed tomogrpahy scans. Clinical efficacy was evaluated using the visual analogue scale (VAS), Owestry disability index (ODI), and short-form health questionnaire-36. The safety of the bone graft substitute was assessed with vital sign monitoring and a survey measuring complications at each follow-up visit.ResultsThere were significant improvements in VAS and ODI scores at a mean 6-month follow-up. Six months after surgery, solid fusion was achieved in all patients. Mean score on the 6-point scoring system was 5.1, and bony formation was found to score at least 4 points in all patients. There was no case with implant-related complications such as cage failure or migration, and no complications associated with the use of CGDBM100.ConclusionACDF using CGDBM100 demonstrated good clinical and radiologic outcomes. The fusion rate was comparable with the published results of traditional ACDF. Therefore, the results of this study suggest that the use of a PEEK cage packed with DBM for ACDF is a safe and effective alternative to the gold standard of autologous iliac bone graft.