Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study.
To evaluate and summarize the 2-year outcomes of patients treated with Osteocel
Plus cellular allograft
as part of an anterior cervical discectomy and fusion
Summary of Background Data. Osteocel
Plus is an allograft cellular bone matrix containing native mesenchymal stem cells
and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest.
A total of 182 patients were treated with anterior cervical discectomy and fusion
Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography
and plain film radiographic measures included assessment of bridging bone
, disc height, disc angle, and segmental range of motion.
A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P
< 0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis.
Improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion
rates provide confidence in Osteocel
Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion
Level of Evidence: 4