NCT07025252

Outcomes for VersaWrap in Achilles Tendon Repair

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Research Source · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the foot and ankle. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

Detailed description

This is a prospective, multi-center, controlled case series evaluating the use of VersaWrap in surgeries of the foot and ankle. Patients identified by the Investigator in his practice as needing surgery for an Achilles primary or elective insertional repair and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

Conditions

• Achilles Tendon Injury

Interventions

Type	Name	Description
DEVICE	VersaWrap	VersaWrap is applied to the affected tendon to allow post-operative gliding.

Timeline

• Start date: 2025-05-13
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study