[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06741527":3,"trial-entities:NCT06741527":251,"trial-summary:NCT06741527":255},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":240,"overall_officials":248,"references":249,"see_also_links":250},"NCT06741527","Protocol 24-01","Integrity Implant System Post Market Clinical Follow-Up Study","Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation","RECRUITING","2027-10","2026-06","2026-06-24","2025-02-01","Anika Therapeutics, Inc.","INDUSTRY",false,"The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).","The Study Objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).\n\nThe clinical success will be evaluated by absence of rotator cuff re-tear. Performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Constant-Murley Score (CMS), Patient Satisfaction, EQ-5D-5L, Single Assessment Numeric Evaluation (SANE), Visual Analogue Scale (VAS) and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration.\n\nSafety of the Integrity Implant System will be assessed by monitoring the frequency and incidence of adverse events.\n\nThe Primary Endpoint shall confirm the Performance of the Integrity Implant System when used for rotator cuff augmentation (with or without repair). Performance will be evaluated by an adequately powered analysis of retear rates seen by MRI at 12-months after surgery.",[19],"Rotator Cuff Tears of the Shoulder",[21,22,23],"Rotator Cuff Repair","Shoulder repair","Integrity Implant","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},150,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Integrity Implant System","Integrity Implant System used for Rotator Cuff Repair",[34],[38],{"measure":39,"description":40,"timeFrame":41},"Re-tear rate after rotator cuff augmentation","Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.","12 months postoperatively",[43,47,51,54],{"measure":44,"description":45,"timeFrame":46},"The American Shoulder and Elbow Surgeons (ASES) Score","The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.","Screening\u002FPre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively",{"measure":48,"description":49,"timeFrame":50},"Constant-Murley Score (CMS)","The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.","Screening\u002FPre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively",{"measure":52,"description":53,"timeFrame":50},"EQ-5D-5L (EuroQol)","The 5-level EQ-5D (EQ-5D-5L) is a standardized self-assessed, health related quality of life questionnaire. It is composed of five questions with Likert scale response options (descriptive system) and a visual analog scale (EQ-VAS). The EQ-VAS asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).",{"measure":55,"description":56,"timeFrame":50},"The Single Assessment Numeric Evaluation (SANE) Score","The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.","ALL","18 Years",null,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"1. At least 18 years of age\n2. Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.\n3. Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.\n4. Fully understands study requirements and able to return for all required follow-up visits and assessments.\n5. Able to comply with all post-operative physician prescribed rehabilitation instructions.\n6. Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention\n7. Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:\n\nIndex shoulder rotator cuff tendon tear needs management and protection from injury\n\nIndex shoulder has no substantial loss of tendon tissue\n\nIndex shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack\n\nIndex shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple\n\nExclusion Criteria\n\nThe subject exclusion criteria are as follows:\n\n1. Medical condition that in the PI's opinion would place the subject at risk or interfere with the study\n2. Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)\n3. Pregnant, breastfeeding, or plans to become pregnant during the study\n4. History of poor compliance with medical treatment of any kind\n5. Deemed contraindicated for MRI by the PI\n6. Previous rotator cuff surgery (any type) on the index shoulder\n7. Current instability of the index shoulder\n8. Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \\>5cm)\n9. Chondromalacia of index shoulder ≥ Grade 3\n10. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3\n11. Insulin dependent Type I Diabetes\n12. History of heavy smoking (≥ 1 pack per day) within last 6-months\n13. History of auto-immune or immunodeficiency disorders\n14. Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)\n15. Oral steroid use in the last 2-months or injectable steroid use in the last 3-months\n16. History of cognitive or mental health status that interferes with study participation\n17. Poor comprehension of English language\n18. Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:\n\n18.1 Rotator cuff tendon tear is deemed irreparable by the PI\n\n18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon\n\n18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue\n\n18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement\n\n18.5 Presence of infection\n\n18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period\n\n18.7 Hypersensitivity to any of the Integrity Implant System components\n\n18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation\n\n18.9 Inadequate quality of bone for Integrity Bone Staple fixation",[65,66],"ADULT","OLDER_ADULT",[68,95,112,131,146,168,183,203,221],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":92},"OrthoArizona","Gilbert","Arizona","85234","United States",[75,80,84,87,90],{"name":76,"role":77,"phone":78,"email":79},"Robert Wallace","CONTACT","800-774-1534","r.wallace@prgresearch.com",{"name":81,"role":77,"phone":78,"phoneExt":82,"email":83},"Audrey Fierro","716","a.fierro@prgresearch.com",{"name":85,"role":86},"Kipling Sharpe, MD","PRINCIPAL_INVESTIGATOR",{"name":88,"role":89},"Keith Jarbo, MD","SUB_INVESTIGATOR",{"name":91,"role":89},"Cory Nelson, MD",{"lat":93,"lon":94},33.35283,-111.78903,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":73,"contacts":100,"geoPoint":109},"Premier Orthopaedic Trauma Specialists, PMC","Pomona","California","91767",[101,105,107],{"name":102,"role":77,"phone":103,"email":104},"Joseph Liu","909-596-4346","jliu@premierortho.org",{"name":106,"role":86},"Joseph N Liu, MD",{"name":108,"role":89},"Nirav Amin, MD",{"lat":110,"lon":111},34.05529,-117.75228,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":73,"contacts":117,"geoPoint":128},"Foundation for Orthopaedic Research and Education","Tampa","Florida","33607",[118,122,126],{"name":119,"role":77,"phone":120,"email":121},"Debbi Warren, RN","844-944-4263","dwarren@foreonline.org",{"name":123,"role":77,"phone":124,"email":125},"Peter Simon, PhD","844-044-4263","psimon@foreonline.org",{"name":127,"role":86},"Christopher Baker, MD",{"lat":129,"lon":130},27.94752,-82.45843,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":73,"contacts":136,"geoPoint":143},"Harbin Clinic","Rome","Georgia","30165",[137,141],{"name":138,"role":77,"phone":139,"email":140},"Terri Brannon","762-235-2612","Terri.Brannon@advocatehealth.org",{"name":142,"role":86},"Brandon Bushnell, MD",{"lat":144,"lon":145},34.25704,-85.16467,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":73,"contacts":151,"geoPoint":165},"Central Indiana Orthopaedics","Fishers","Indiana","46037",[152,156,161,163],{"name":153,"role":77,"phone":154,"email":155},"Brad Crackel, ATC","317-773-4301","brad_crackel@ciocenter.com",{"name":157,"role":77,"phone":158,"phoneExt":159,"email":160},"Derek Yocum, PhD","574-247-9441","5199","DYocum@sbortho.com",{"name":162,"role":86},"Brian Badman, MD",{"name":164,"role":89},"Aaron Baessler, MD",{"lat":166,"lon":167},39.95559,-86.01387,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":73,"contacts":173,"geoPoint":180},"Towson Orthopaedic Associates\u002FUniversity of Maryland St. Joseph's Medical Center","Towson","Maryland","21204",[174,178],{"name":175,"role":77,"phone":176,"email":177},"Debbie Codd","410-218-4499","debbie.codd@comcast.net",{"name":179,"role":86},"Timothy Codd, MD",{"lat":181,"lon":182},39.4015,-76.60191,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":73,"contacts":188,"geoPoint":200},"Virtua Health","Marlton","New Jersey","08053",[189,194,198],{"name":190,"role":77,"phone":191,"phoneExt":192,"email":193},"Donna Hoopes","856-355-1206","1206","Dhoopes@virtua.org",{"name":195,"role":77,"phone":196,"email":197},"Kristin Broderick","856-355-1225","Kbroderick@virtuahealth.org",{"name":199,"role":86},"Sean McMillan, DO",{"lat":201,"lon":202},39.89122,-74.92183,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":73,"contacts":208,"geoPoint":218},"Steadman Hawkins Clinic of the Carolinas","Greenville","South Carolina","29615",[209,213,216],{"name":210,"role":77,"phone":211,"email":212},"Allison Nall, MS","864-454-7458","Allison.nall@hawkinsfoundation.com",{"name":214,"role":77,"phone":211,"email":215},"Allyson Sandago","Allyson.sandago@hawkinsfoundation.com",{"name":217,"role":86},"Stephan G Pill, MD",{"lat":219,"lon":220},34.85262,-82.39401,{"facility":222,"status":8,"city":223,"state":224,"zip":225,"country":73,"contacts":226,"geoPoint":237},"Campbell Clinic","Germantown","Tennessee","38138",[227,231,235],{"name":228,"role":77,"phone":229,"email":230},"Lucy Del Mar, MD","901-759-5495","ldelmar@campbell-foundation.org",{"name":232,"role":77,"phone":233,"email":234},"Margaret Knack, RN","901-759-5413","mknack@campbell-foundation.org",{"name":236,"role":86},"Thomas W Throckmorton, MD",{"lat":238,"lon":239},35.08676,-89.81009,[241,245],{"name":242,"role":77,"phone":243,"email":244},"Kara Mezger","781-457-9000","kmezger@anika.com",{"name":246,"role":77,"phone":243,"email":247},"Jennifer Williams","jlwilliams@anika.com",[],[],[],{"nct_id":4,"conditions":252,"biomarkers":254},[253],"Rupture of rotator cuff of shoulder",[],{"nct_id":4,"found":256,"summary":257,"prompt_version":267},true,{"design":258,"status":259,"heading":260,"summary":261,"follow_up":262,"word_count":263,"commitments":264,"compensation":265,"drugs_mentioned":266},"This study is a single-arm study, meaning all 150 participants will receive the Integrity Implant System. It is a post-market study, following the device after it's been approved.","completed","Integrity Implant System for Rotator Cuff Tears","This study is looking at how well the Integrity Implant System works for people with rotator cuff tears in their shoulder. This system is used to help repair the torn rotator cuff. Researchers want to see if it helps prevent the tear from happening again. You might be able to join if you are at least 18 years old and can understand the study information. The main goal is to see the re-tear rate (how often the tear comes back) after 12 months. The study is currently unclear about its recruitment status.","Your re-tear rate will be measured at 12 months after your surgery.",92,"You would complete Patient Reported Outcome Measure (PROM) questionnaires and have MRI evaluations for your shoulder repair integrity, quality, tendon tissue thickness, and regeneration.","Not stated in the trial record.",[34],"v2"]