Outcomes for VersaWrap in Achilles Tendon Repair
Enrolling by invitation
Conditions studied: Achilles Tendon Injury
In brief
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
Key facts
- Study ID
- NCT07025252
- Run by
- Research Source
- People needed
- 400
- Starts
- 2025-05-13
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
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)
Where it is running
- UC Davis Foot and Ankle Orthopaedics Clinic — Sacramento, California, United States
- Rothman Orthopaedics Institute — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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