By InvitationNot Applicable

Outcomes for VersaWrap in Achilles Tendon Repair

United States400 participantsStarted 2025-05-13

Plain-language 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

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Skin Excursion

Timeframe: 12 months post surgery

Range of Motion (ROM)

Timeframe: 12 months post surgery

Trial details

NCT IDNCT07025252

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Achilles Tendon Injury trials