[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100340907":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":75,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":34,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":34,"enrollmentInfo":91,"targetDuration":34,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.",[13,14],"Procedure: Lateral Epicondylectomy","Radiation: Ultrasound Imaging",{"label":16,"type":17,"description":18,"interventionNames":19},"Experimental","EXPERIMENTAL","Identical surgical treatment plus Smith \\& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.",[20,13,14],"Biological: Smith & Nephew Bioinductive Implant",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Smith & Nephew Bioinductive Implant","A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.",[16],[28],"Bioinductive Patch",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Lateral Epicondylectomy","This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.",[9,16],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"RADIATION","Ultrasound Imaging","An ultrasound will be performed on each patient both preoperatively and at 6 months.",[9,16],[41],{"name":42,"affiliation":5,"role":43},"Stephanie J Muh, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Johnny Kasto, MD","CONTACT","3132448078","jkasto1@hfhs.org",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Henry Ford Hospital","RECRUITING","Detroit","Michigan","48202","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-83.04575,42.33143,{"lat":63,"lon":62},[66,67,68,71,73],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},{"name":42,"role":43,"phone":34,"phoneExt":34,"email":34},{"name":69,"role":70,"phone":34,"phoneExt":34,"email":34},"Eric C Makhni, MD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":34,"phoneExt":34,"email":34},"Vasilios Moutzouros, MD",{"name":74,"role":70,"phone":34,"phoneExt":34,"email":34},"Elizabeth King, MD",{"type":43,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Stephanie Muh, MD","Deputy Service Chief, Principal Investigator",[79],{"name":80,"class":81},"Smith & Nephew, Inc.","INDUSTRY","100340907","phase-4-efficacy-bioinductive-implant-for-tennis-elbow-lateral-epicondylitis-100340907",false,"NCT03718637","Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)","Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)","Inclusion Criteria:\n\n* Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.\n\nExclusion Criteria:\n\n* Previous surgery on the currently-affected elbow.","MALE","18 Years",{"count":92,"type":93},40,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the \"control group\" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the \"experimental group\" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.",[99,100],"Tennis Elbow","Lateral Epicondylitis",[99,102,100,103],"Tendinopathy","Bioinductive","2025-03-10",{"date":106,"type":107},"2025-03-12","ACTUAL",{"date":109,"type":107},"2019-04-17",{"date":111,"type":93},"2027-01-17",{"name":5,"class":6},1]