Outcomes for VersaWrap in Achilles Tendon Repair

Research Source

Status: Invitation-only

Conditions: Achilles Tendon Injury

Treatments: Device: VersaWrap

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07025252

TP-068

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
3. Age ≥18 years and <90 years at the time of surgery

Exclusion criteria

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

Trial design

400 participants in 1 patient group

VersaWrap

Description:

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

Treatment:

Device: VersaWrap