Prospective, Multicenter Evaluation of Allogeneic Bone Matrix Containing Viable Osteogenic Cells in Foot and/or Ankle Arthrodesis

Abstract

Level II, prospective study.

A Retrospective Clinical Comparison of Two Allogeneic Bone Matrices Containing Viable Osteogenic Cells in Patients Undergoing Foot and/or Ankle Arthrodesis

“…This study sought to stratify these groups out of the entire population and determine if fusion rates and clinical outcomes would be impacted. Similar to the Jones, et al [18], study, the current study demonstrated no notable differences in fusion rates between normal and groups with risk factors. No significant differences in fusion rates were observed between subjects that had diabetes, were greater than 65 years of age, or were obese /morbidly obese as compared to those that were not.…”

“…However, since harvesting autograft bone results in well-known complications [12][13][14][15], CBA has been used since it lacks the patient morbidity associated with autograft harvest yet shares the three characteristics that are required for effective bone formation, an osteoconductive scaffold, osteoinductive growth factors and osteogenic cells. In a previous publication, the fusion rate using CBA after foot and/or ankle arthrodesis was higher than or comparable to historical autograft fusion rates [18]. For autograft, the per subject fusion rates were 66.4% (91/137) and 75.2% (103/137) at 6 and 12 months, respectively [2].…”

“…The fusion rate using T EV was higher than or comparable to historical autograft fusion rates and was not adversely affected by several high-risk patient factors [18]. A new form of CBA, Trinity ELITE  (T EL ), was subsequently developed that contains a validated, minimum cell number that is two-fold greater than T EV .…”

“…Previously, one CBA, Trinity Evolution  (T EV ) has been evaluated as an adjunct for foot and ankle arthrodesis in a prospective multicenter study of 76 patients [18]. The fusion rate using T EV was higher than or comparable to historical autograft fusion rates and was not adversely affected by several high-risk patient factors [18].…”

A Comparative Evaluation of Commercially Available Cell-Based Allografts in a Rat Spinal Fusion Model

“…The Trinity Evolution and Osteocel allografts have been evaluated separately in 3 clinical studies for foot and ankle arthrodesis and lumbar interbody fusion. [15][16][17] However, neither side-by-side comparisons of these products nor comparisons with autograft controls have been performed. Our study indicates that allograft cell preparations do not all perform the same in vivo.…”