[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07025252":3,"trial-entities:NCT07025252":82,"trial-summary:NCT07025252":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":49,"locations":52,"central_contacts":78,"overall_officials":79,"references":80,"see_also_links":81},"NCT07025252","TP-068","Outcomes for VersaWrap in Achilles Tendon Repair","ENROLLING_BY_INVITATION","2028-06","2025-06","2025-06-17","2025-05-13","Research Source","NETWORK",false,"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","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.",[18],"Achilles Tendon Injury",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},400,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","VersaWrap","VersaWrap is applied to the affected tendon to allow post-operative gliding.",[29],[33,37],{"measure":34,"description":35,"timeFrame":36},"Skin Excursion","Skin excursion will be measured by examining the movement that is regularly repeated in a portion of involved skin in comparison to movement of the skin in the peroneal region of the contralateral foot. A ruler will be utilized to measure the up and down movement at the center of the skin excision, to determine the exact amount of excursion of the center of the wound.","12 months post surgery",{"measure":38,"description":39,"timeFrame":36},"Range of Motion (ROM)","Standing dorsi- and plantarflexion of the affected and contralateral ankle will be measured using a handheld goniometer, referencing the long axis of the fibula and fifth metatarsal shaft. Both passive and active range of motion will be captured. The greater the ROM the better the outcome.",[],"ALL","18 Years","90 Years",true,{"inclusion":46,"exclusion":47,"raw_text":48},[],[],"Inclusion Criteria:\n\n1. 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.\n2. Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol\n3. Age ≥18 years and \\\u003C90 years at the time of surgery\n\nExclusion Criteria:\n\n1. Investigator determines that the subject is unlikely to comply with the requirements of the study\n2. Active systemic infection or infection at the location planned surgery\n3. Uncontrolled diabetes\n4. Prior Achilles surgery on either ankle\n5. Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included\n6. Morbid obesity defined as a body mass index \\> 40\n7. Pregnant or have plans to become pregnant in the next year\n8. Currently a prisoner\n9. Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis)\n10. Medications that could interfere with fusion or other bone\u002Fsoft tissue healing (e.g., anticipated continued use of systemic steroid medication postoperatively)",[50,51],"ADULT","OLDER_ADULT",[53,62,70],{"facility":54,"city":55,"state":56,"zip":57,"country":58,"geoPoint":59},"UC Davis Foot and Ankle Orthopaedics Clinic","Sacramento","California","95816","United States",{"lat":60,"lon":61},38.58157,-121.4944,{"facility":63,"city":64,"state":65,"zip":66,"country":58,"geoPoint":67},"Rothman Orthopaedics Institute","Philadelphia","Pennsylvania","19107",{"lat":68,"lon":69},39.95238,-75.16362,{"facility":71,"city":72,"state":73,"zip":74,"country":58,"geoPoint":75},"Medical University of South Carolina","Charleston","South Carolina","29452",{"lat":76,"lon":77},32.77632,-79.93275,[],[],[],[],{"nct_id":4,"conditions":83,"biomarkers":85},[84],"Injury of Achilles tendon",[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]