Outcomes for VersaCoreTM Hydrogel Technology (VersaWrap® Tendon Protector, VersaCoatTM Tendon Protector) in Achilles Tendon Repair

Date Added
January 2nd, 2025
PRO Number
Pro00136177
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Bone, Joint, Pain, Surgery
Summary

The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.

Institution
MUSC
Recruitment Contact
Jagan Kandadai
2148422519
kandadai@musc.edu



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