[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100406400":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":85,"collaborators":26,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Biodegradable spacer","EXPERIMENTAL","Intervention group",[13,14],"Procedure: Biodegradable spacer","Procedure: Debridement and biceps tenotomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B: control group","ACTIVE_COMPARATOR","Control group",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biodegradable spacer","Implantation of a biodegradable balloon used as a subacromial spacer.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Debridement and biceps tenotomy","Surgery with arthroscopic debridement and biceps tenotomy",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Hannah Ugletveit Jahr, Cand. med","Hospital of southern Norway","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Hannah Ugletveit Jahr, Cand. med.","CONTACT","+47 90762377","hannah.jahr@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Berte Bøe, PhD","+47 41338451","uxbebm@ous-hf.no",[47,69],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hospital of Southern Norway, Arendal","RECRUITING","Arendal","4848","Norway","NO",{"type":55,"coordinates":56},"Point",[57,58],8.77253,58.46151,{"lat":58,"lon":57},[61,65],{"name":62,"role":39,"phone":63,"phoneExt":26,"email":64},"Hannah U. Jahr, Cand.med","+4790762377","hannahuj@sshf.no",{"name":66,"role":39,"phone":67,"phoneExt":26,"email":68},"Marek W Zegzdryn, cand.med","+4791143329","marek.walerian.zegzdryn@sshf.no",{"facility":70,"status":71,"city":72,"state":26,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Oslo university hospital","NOT_YET_RECRUITING","Oslo","0424",{"type":55,"coordinates":75},[76,77],10.74609,59.91273,{"lat":77,"lon":76},[80,82],{"name":43,"role":39,"phone":81,"phoneExt":26,"email":45},"+4741338451",{"name":83,"role":39,"phone":26,"phoneExt":26,"email":84},"Ragnhild Støen, PhD","stox@ous.hf.no",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hannah U. Jahr","Resident in Orthopedic surgery","100406400","arthroscopic-treatment-of-massive-rotator-cuff-tears-with-debridement-and-biodegradable-spacer-100406400",false,"NCT04571918","Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.","Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.","AMRIS","Inclusion Criteria:\n\n* Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.\n* Persistent pain for at least 3 months, with documented failure of conservative treatment\n* Age ranging from 60 years of age to 85 years of age\n\nExclusion Criteria:\n\n* Significant shoulder osteoarthritis in the affected shoulder, Hamada classification \\>2.\n* Total rupture of subscapularis tendon and\u002For teres minor, classified B and E in the Collins classification.\n* Comorbidity to the degree that the patient will not be able to participate in the follow up program.","ALL","60 Years","85 Years",{"count":101,"type":102},50,"ESTIMATED","INTERVENTIONAL",[105],"NA","Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.\n\nThe study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.",[108],"Massive Rotator Cuff Tears",[110,23,111],"Ballon spacer","Subacromial spacer","2020-09-25",{"date":114,"type":115},"2020-10-01","ACTUAL",{"date":117,"type":102},"2020-11-01",{"date":119,"type":102},"2029-09-01",{"name":5,"class":6},2]