Clinical trial NCT07025252: Outcomes for VersaWrap in Achilles Tendon Repair
Official title: Outcomes for VersaWrap in Achilles Tendon Repair
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Achilles Tendon Injury
Lead sponsor: Research Source
Sponsor class: NETWORK
First posted: 2025-06-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Skin Excursion
timeFrame: 12 months post surgery
measure: Range of Motion (ROM)
timeFrame: 12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Foot and Ankle Orthopaedics Clinic
state: California
city: Philadelphia
country: United States
facility: Rothman Orthopaedics Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: