Outcomes for VersaWrap in Achilles Tendon Repair

NCT07025252 | Enrolling By Invitation FDA Device

• 1 other identifier: TP-068
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Achilles Tendon Injury

Outcome Measures

Primary Outcomes (2)

• Skin Excursion

  Skin excursion will be measured by examining the movement that is regularly repeated in a portion of involved skin in comparison to movement of the skin in the peroneal region of the contralateral foot. A ruler will be utilized to measure the up and down movement at the center of the skin excision, to determine the exact amount of excursion of the center of the wound.

  12 months post surgery

• Range of Motion (ROM)

  Standing dorsi- and plantarflexion of the affected and contralateral ankle will be measured using a handheld goniometer, referencing the long axis of the fibula and fifth metatarsal shaft. Both passive and active range of motion will be captured. The greater the ROM the better the outcome.

  12 months post surgery

Study Arms (1)

VersaWrap

All enrolled patients will received VersaWrap applied prior to surgical closure on the affected tendon.

Device: VersaWrap

Interventions

VersaWrap DEVICE

VersaWrap is applied to the affected tendon to allow post-operative gliding.

VersaWrap

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the following inclusion criteria and none of the exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize the VersaWrap, the patient will be considered a screen failure.

You may qualify if:

• Patients that require surgery for Achilles primary or elective insertional repair. Note: primary repair must be conducted within 6 weeks of injury. Additional repairs may be conducted during surgery, confirm with study Sponsor prior to enrollment. Insertional repairs due to trauma are not eligible.
• Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
• Age ≥18 years and \<90 years at the time of surgery

You may not qualify if:

• Investigator determines that the subject is unlikely to comply with the requirements of the study
• Active systemic infection or infection at the location planned surgery
• Uncontrolled diabetes
• Prior Achilles surgery on either ankle
• Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included
• Morbid obesity defined as a body mass index \> 40
• Pregnant or have plans to become pregnant in the next year
• Currently a prisoner
• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis)
• Medications that could interfere with fusion or other bone/soft tissue healing (e.g., anticipated continued use of systemic steroid medication postoperatively)

Sponsors & Collaborators

• Research Source: lead

Study Sites (3)

UC Davis Foot and Ankle Orthopaedics Clinic

Sacramento, California, 95816, United States

Location

Rothman Orthopaedics Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29452, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)