[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499822":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":11,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":11,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":11},{"fullName":5,"class":6},"Panam Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Subacromial spacer implantation","EXPERIMENTAL",null,[13],"Procedure: Subacromial spacer implantation",{"label":15,"type":16,"description":11,"interventionNames":17},"Rotator Cuff Repair","ACTIVE_COMPARATOR",[18],"Procedure: Rotator cuff repair",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Rotator cuff repair","Rotator cuff repair with tenotomy of long head of biceps.",[15],[29],{"name":30,"affiliation":31,"role":32},"Jarret Woodmass, MD","Pan Am Clinic","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Sheila McRae, PhD","CONTACT","204-925-7469","smcrae@panamclinic.com",{"name":40,"role":36,"phone":41,"phoneExt":11,"email":42},"Brenna Cyr, BKin","204-927-2828","bcyr@panamclinic.com",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[46],{"name":47,"class":6},"University of Manitoba","100499822","rc-repair-versus-subacromial-balloon-spacer-in-older-adults-100499822",false,"NCT05788250","RC Repair Versus Subacromial Balloon Spacer in Older Adults","Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation","Inclusion Criteria:\n\n* 70 years of age or older\n* clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear \\>2cm or more than 1 full tendon\n* ongoing symptoms after 3 months of physiotherapy\n* a tendon amenable to partial or complete repair (as determined by pre-operative MRI)\n* absence glenohumeral arthritis (Hamada \\\u003C 3)\n* absence of neoplastic diseases at treated site\n\nExclusion Criteria:\n\n* previous surgery or pseudoparalysis on study shoulder\n* complete subscapularis deficiency\n* external rotation lag signs\n* avascular necrosis\n* post-infectious arthritis\n* proximal humerus fracture\n* inflammatory arithritis\n* axillary nerve palsy\n* concomitant tendon transfer\n* neuromuscular disorder\n* unable to speak\u002Fread English\n\nIntra-operative Exclusion:\n\n-tendon is NOT amenable to partial or complete repair","ALL","70 Years",{"count":58,"type":59},32,"ESTIMATED","INTERVENTIONAL",[62],"NA","The purpose of this pilot study is to assess the feasibility of a full randomized trial design.",[65],"Rotator Cuff Tears",[67,68,69],"rotator cuff repair","subacromial spacer","older adults","NOT_YET_RECRUITING","2024-04-01",{"date":73,"type":74},"2024-04-02","ACTUAL",{"date":76,"type":59},"2024-08",{"date":78,"type":59},"2027-10",{"name":5,"class":6}]