StayFuse™ Intramedullary Implant Stabilization For Management of the Floppy Toe Following Hammertoe Correction Surgery
Authors: Lynch Mary-Katherine , Raikin Steven , Sutton Ryan 
Published: October 2016

Category: Lesser Toes Introduction/Purpose: Though typically hammertoe correction surgery is successful, there are two possible outcomes that necessitate a second surgical procedure. Over time the hammertoe deformity may recur, or occasionally too much bone will be resected in the primary surgery resulting in an unstable or “floppy toe”. The floppy toe can be very difficult to manage, often requiring bone grafting to obtain fusion and stability. The StayFuse™ intramedullary implant is a two piece double ended screw device which can be implanted into the phalangeal remnants and interdigitated to permanently stabilize and align the toe in the correct position. The purpose of this study was to gather outcome data from patients treated with the StayFuse™ intramedullary implant in these revision procedures. Methods: Following IRB approval, a retrospective analysis of 32 patients who had been treated with the StayFuse™ intramedullary implant for unstable floppy toe deformities was undertaken. Demographic information collected included gender, age, time from initial hammertoe surgery, and number of previous procedures they had undergone on the involved foot, and involved toe. In addition, preoperative questionnaire scores were reviewed. The second toe was involved in 25 cases (78%), the 3rd toe in 11 cases (34%), and the 4th toe in 2 cases (6%). 6 required implantation in their 2nd and 3rd toes. Each patient underwent an average of 2.9 procedures during their revision surgery. Patients were evaluated at an average of 54 months post- surgery and completed a VAS Pain Score, Foot and Ankle Ability Measure (FAAM), Veterans Rand 12 Item Health Survey (VR-12), and a patient satisfaction survey. Univariate analysis was then performed. Results: The study population was 94% female with a mean age of 59.1 years. Patients had waited an average of 3.7 years before undergoing their revision procedure. At final follow-up, patients reported an average pain level of 2.7/10 in their involved toe as compared to 6.8/10 before implantation. The average final FAAM ADL score was 63.81/100, and Sports score 46.50/100. The average VR-12 Physical score was 40.84 and Mental score was 61.50. Six patients reported being “Extremely dissatisfied” with the outcome of their surgery, 3 were “Somewhat dissatisfied”, 4 were “Neither dissatisfied nor satisfied”, 6 were “Satisfied” and 12 were “Extremely satisfied”. Patients reporting being “dissatisfied” had undergone an average of 3.87 previous surgeries on their foot, compared to 2.84 previous surgeries in “satisfied” group (p < 0.05) Conclusion: The floppy toe following an over-resected distal condylectomy of the proximal phalanx during a hammertoe correction remains a difficult problem to manage. By utilizing an intramedullary implant to stabilize the joint, the present study found that 56% (18/32) patients were satisfied with the outcome of their salvage surgery, while 13% (4/32) were neither dissatisfied nor satisfied. Unfortunately 28% (9/32) patients were dissatisfied. We conclude that the StayFuse™ intramedullary implant is a reasonable option for revision of unstable “floppy toes”. Patients should be counseled at length before consenting to surgery so that postoperative expectations may be better managed.