An Open-label, Single-center, Retrospective Study of Cryopreserved Amniotic Membrane and Umbilical Cord Tissue as an Adjunct for Foot and Ankle Surgery.

The primary aim of this study was to compare preoperative assessments with postoperative outcomes from patients undergoing foot and ankle revisions and/or complex reconstructions with tendon and/or nerve involvement using cryopreserved human amniotic membrane and umbilical cord (cHAM/UC). We hypothesized complex foot and ankle surgery using amniotic membrane would be an effective treatment leading to reduced pain and improved functional outcomes. Fourteen patients (6 male and 8 female) underwent open foot and ankle surgery during the study period. All 14 patients included in this cohort reported improvement, namely, lessened pain intensity both on the American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale and the pain numeric rating scale (NRS), as well as improved functional status. The mean AOFAS score improved from 50 (range, 17-79) preoperatively to 85 (range, 67-100) postoperatively. The mean NRS score also improved from 8 (range, 4-10) preoperatively to 2 (range, 0-6) postoperatively with a mean percent change in pain NRS of 78% (range 17-100%). Both outcome-scoring systems showed statistically significant differences (p < .0001) when we compared the preoperative and postoperative results. All patients included in the cohort showed improvement in both outcome measures. Further study of long-term endpoints is warranted.