1. Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion
- Author
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Timothy Peppers, Rebekah Hahn, Brent Atkinson, James T. Ryaby, Erik I. Waldorff, Jed S. Vanichkachorn, Scott K. Stanley, Paul M. Arnold, Dennis E. Bullard, and Raymond Linovitz
- Subjects
Adult ,Male ,medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,Visual analogue scale ,Radiography ,Arthrodesis ,medicine.medical_treatment ,Bone Matrix ,Anterior cervical discectomy and fusion ,Subgroup analysis ,Intervertebral Disc Degeneration ,Transplantation, Autologous ,03 medical and health sciences ,0302 clinical medicine ,lcsh:Orthopedic surgery ,Allograft ,Cervical spine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Spine fusion ,Prospective Studies ,Adverse effect ,ACDF ,Aged ,030222 orthopedics ,Bone Transplantation ,business.industry ,Middle Aged ,Multilevel ,Surgery ,lcsh:RD701-811 ,Spinal Fusion ,Orthopedic surgery ,Cervical Vertebrae ,Female ,PEEK cage ,lcsh:RC925-935 ,Stem cell ,business ,030217 neurology & neurosurgery ,Research Article ,Diskectomy - Abstract
Background Trinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures. Methods In a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months. Results At both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p
- Published
- 2017