Cheilectomy With or Without Cryopreserved Amniotic Membrane–Umbilical Cord Allograft for Hallux Rigidus

BACKGROUND: For hallux rigidus, dorsal cheilectomy remains a treatment option even with advances in interposition techniques and devices. Cheilectomy aims to alleviate dorsal impingement and improve pain and function as well as range of motion. Cryopreserved umbilical cord allograft, with properties to mitigate inflammation and scar formation, has theoretical benefit for improving outcomes following cheilectomy. In this first prospective randomized and blinded cheilectomy study reported, we aimed to compare outcomes between cheilectomy alone and cheilectomy with umbilical cord allograft. METHODS: Patients were randomized to cheilectomy alone (CA) or cheilectomy with cryopreserved umbilical cord (ie, amniotic membrane–umbilical cord [AM-UC]). Patients were evaluated with American Orthopaedic Foot & Ankle Society (AOFAS), Foot Function Index (FFI), and visual analog scale (VAS) pain outcomes collected preoperatively and at 6 months and 1 year postoperatively. In addition, radiographic range of motion data were collected using stress radiographs. Fifty-one patients (26 AM-UC, 25 CA) completed the study, with 5 bilateral surgeries in the AM-UC group and 2 in the CA group, totaling 31 and 27 feet, respectively. RESULTS: The AM-UC group had statistically significant improved AOFAS and FFI scores at 1 year compared with the CA group, but there was no difference at 6 months. There was no significant difference between groups for VAS-pain scores at any time point, but overall VAS-pain improved in both groups from preoperative values. There was no significant difference in range of motion (total arc) between groups and changes in range of motion (total arc) in both groups from preoperative to 1 year postoperative were small. CONCLUSION: We present the results of the first randomized and blinded prospective study of cheilectomy surgery patients. When appropriately selected, cheilectomy remains a good option for patients with symptomatic hallux rigidus. Cryopreserved umbilical cord is a potential adjuvant to cheilectomy, with 1-year results showing improvements in functional outcome scores. LEVEL OF EVIDENCE: Level II, prospective comparative study.