Outcomes for VersaWrap in Achilles Tendon Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VersaWrap.
- Who it may be relevant to
- Registry conditions: Achilles Tendon Injury. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device VersaWrap
VersaWrap is applied to the affected tendon to allow post-operative gliding.
Primary outcome measures
- Skin Excursion [Time frame: 12 months post surgery]
- Range of Motion (ROM) [Time frame: 12 months post surgery]
Eligibility criteria
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- UC Davis Foot and Ankle Orthopaedics Clinic — Sacramento
- Rothman Orthopaedics Institute — Philadelphia
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT07025252 · TP-068