[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446628":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":44,"responsibleParty":63,"collaborators":42,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":42,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Allina Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryo-compression","EXPERIMENTAL","Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a \"Medium\" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and \"Level 3\" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion.",[13],"Device: Cryo-compression",{"label":15,"type":16,"description":17,"interventionNames":18},"Cryo-therapy","ACTIVE_COMPARATOR","Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.",[19],"Other: Cryo-therapy",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Programmable intermittent compression with integrated cryo-therapy.",[9],[26],"NICE Cold Therapy",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Subjects are fitted with gel ice packs and wraps.",[15],[31],"Gel ice pack",[33],{"name":34,"affiliation":35,"role":36},"L Pearce McCarty III, MD","Allina Health","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Ned Tervola, MA, LAT, ATC","CONTACT","952-946-9777",null,"ned.tervola@allina.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Allina Health Orthopedics","RECRUITING","Plymouth","Minnesota","55441","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-93.45551,45.01052,{"lat":57,"lon":56},[60,62],{"name":61,"role":40,"phone":41,"phoneExt":42,"email":43},"Ned K Tervola, MA, LAT, ATC",{"name":34,"role":36,"phone":42,"phoneExt":42,"email":42},{"type":64,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100446628","utility-of-intermittent-cryo-compression-versus-traditional-icing-following-arthroscopic-rotator-cuff-repair-100446628",false,"NCT05095909","Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair","ICC","Inclusion Criteria:\n\n1. Patients who are candidates for arthroscopic rotator cuff repair\n\n   1. Acute, traumatic tear of the rotator cuff in an active patient\n   2. Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment\n2. Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.\n3. ≥18 years of age\n\nExclusion Criteria:\n\n1. Pregnancy (per pre-operative physical)\n2. Presence of significant glenohumeral joint osteoarthritis\n3. Age over 70\n4. History of clinically diagnosed lymphedema\n5. Morbid obesity (BMI \\> 45)\n6. History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative)\n7. Investigators concern regarding subject's ability or willingness to follow protocol.\n8. History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia).\n9. History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia.\n10. History of Raynaud's disease or cold hypersensitivity (cold urticarial).",true,"ALL","18 Years","70 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.",[84,85],"Rotator Cuff Injuries","Cryotherapy Effect",[9,87],"Rotator cuff repair","2026-01-26",{"date":90,"type":91},"2026-01-27","ACTUAL",{"date":93,"type":91},"2024-08-05",{"date":95,"type":78},"2026-12",{"name":5,"class":6},1]