A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation.

BACKGROUND

ViviGen is an allogeneic cellular bone matrix product containing lineage-committed bone cells, and can be used as an alternative to autograft bone or other augments to aid in arthrodesis or to enhance bony healing in open reduction and internal fixation (ORIF) procedures.

METHODS

This study included 153 consecutive patients undergoing ankle, midfoot, or hindfoot arthrodesis or ORIF procedures from January 2017 to October 2018, in which an allogeneic cellular bone matrix product was used to aid in bony healing. Retrospective chart review identified patient demographic factors and medical comorbidities and evaluated clinical and radiographic data to determine fusion/union rate and complications.

RESULTS

The overall fusion rate for the arthrodesis cohort was 97/113 (85.8%). The overall complication rate in this cohort was 22/113 (19.5%). Smokers had significantly lower rates of fusion compared with nonsmokers ( = .01). The observed bony healing rate for the ORIF cohort was 19/22 (86.4%), with a complication rate of 3/22 (13.6%).

CONCLUSION

With satisfactory fusion rates and relatively few complications, our findings suggest that ViviGen is a safe and efficacious alternative to other forms of bone graft augmentation for fusion and ORIF procedures about the foot and ankle. Further study is needed to compare the efficacy of ViviGen with autograft bone and other augments.

LEVELS OF EVIDENCE

Level IV: Case series.