[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356510":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":88,"studyPopulation":88,"armGroups":92,"interventions":98,"overallOfficials":106,"centralContacts":110,"locations":117,"responsibleParty":135,"collaborators":88,"id":139,"slug":88,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":88,"eligibilityCriteria":143,"healthyVolunteers":140,"sex":144,"minAge":145,"maxAge":88,"enrollmentInfo":146,"targetDuration":88,"studyType":149,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":120,"whyStopped":88,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":48},[9,13,15,18,19,22,23,26,27,30,31,34],{"measure":10,"description":11,"timeFrame":12},"Active Nerve Denervation","EMG examination will be performed by a single neurologist. The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for any presence or absence of active denervation. Presence indicated by increased insertional activity, fibrillation potential, positive sharp waves and\u002For with fasciculations in both operated and unoperated shoulders.","one year post surgery",{"measure":10,"description":11,"timeFrame":14},"two year post surgery",{"measure":16,"description":17,"timeFrame":12},"Neuropathic Changes_amplitude","The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts, in both operated and unoperated shoulders.",{"measure":16,"description":17,"timeFrame":14},{"measure":20,"description":21,"timeFrame":12},"Neuropathic Changes_recruitment pattern","The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology: phases with recruitment pattern measured as 1-2 or 3-4 units in both operated and unoperated shoulders.",{"measure":20,"description":21,"timeFrame":14},{"measure":24,"description":25,"timeFrame":12},"Neuropathic Changes_duration","The EMG Examination will be performed on the muscles in both operated and unoperated shoulders to look for the presence or absence of neuropathic changes assessed by examining unit morphology: duration measured in milliseconds.",{"measure":24,"description":25,"timeFrame":14},{"measure":28,"description":29,"timeFrame":12},"Total number of Muscles affected with active denervation","The EMG Examination will be performed to look for abnormal changes as indicated by presence of active nerve denervation across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders.",{"measure":28,"description":29,"timeFrame":14},{"measure":32,"description":33,"timeFrame":12},"Total number of muscles affected with neuropathic changes","The EMG Examination will be performed to look for neuropathic changes as indicated by amplitude, recruitment pattern and duration across the 5 muscles (upper subscapularis, Infraspinatus, Supraspinatus, teres minor, Rhomboid) in both operated and unoperated shoulders.",{"measure":32,"description":33,"timeFrame":14},[36,39,40,43,44,47],{"measure":37,"description":38,"timeFrame":12},"Tear in Rotator Cuff Muscles in both shoulders","CT Scan to evaluate rotator cuff muscles for presence or absence of any tear in operative and non-operative. If tear is present - partial or full. If full, small or (\\\u003C1cm), or medium (1-3 cm\\_ or Large (3-5 cm) or massive (\\>5cm), tendon involved (supraspinatus or infraspinatus or subscapularis).",{"measure":37,"description":38,"timeFrame":14},{"measure":41,"description":42,"timeFrame":12},"Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification","CT scan to evaluate atrophy in Rotator Cuff Muscles using the Goutallier Classification System. The Classification system measures fatty tissue infiltration and has five stages, ranging from Stage 0 (normal muscle) to Stage 4 (more fat than muscle) in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid in both operated and unoperated shoulder.",{"measure":41,"description":42,"timeFrame":14},{"measure":45,"description":46,"timeFrame":12},"Fatty atrophy in Rotator Cuff Muscles in both shoulders","CT Scan to evaluate fatty degeneration in Rotator Cuff Muscles - present or absent in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid muscles in both operated and unoperated shoulders.",{"measure":45,"description":46,"timeFrame":14},[49,52,53,56,57,60,61,64,65,68,69,72,73,76,77,80,81,84],{"measure":50,"description":51,"timeFrame":12},"Forward Elevation for Active Range of Motion","A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.",{"measure":50,"description":51,"timeFrame":14},{"measure":54,"description":55,"timeFrame":12},"Forward Elevation for Passive Range of Motion","A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.",{"measure":54,"description":55,"timeFrame":14},{"measure":58,"description":59,"timeFrame":12},"External Rotation (side) for Passive Range of Motion","A physical exam will be performed on both shoulders to asses external rotation (side) for passive range of motion using a Goniometer.",{"measure":58,"description":59,"timeFrame":14},{"measure":62,"description":63,"timeFrame":12},"External Rotation (side) for Active Range of Motion","A physical exam will be performed on both shoulders to asses external rotation (side) for active range of motion using a Goniometer.",{"measure":62,"description":63,"timeFrame":14},{"measure":66,"description":67,"timeFrame":12},"Range of Motion in both shoulders_ Internal Rotation","Physical exam to see range of motion includes:\n\nInternal Rotation measured as T5 or T7 or TL or Belt or Butt or Side",{"measure":66,"description":67,"timeFrame":14},{"measure":70,"description":71,"timeFrame":12},"Measurement of strength in both shoulders_Jobe's test","Measurement of Strength: measured by Isometer in Kg",{"measure":70,"description":71,"timeFrame":14},{"measure":74,"description":75,"timeFrame":12},"Measurement of strength in both shoulders_External Rotation (at side)","Measurement of Strength: External Rotation (at side) measured by Isometer in Kg",{"measure":74,"description":75,"timeFrame":14},{"measure":78,"description":79,"timeFrame":12},"Measurement of strength in both shoulders_Belly Press","Measurement of Strength:Belly Press measured as Positive\u002FNegative\u002FUnable",{"measure":78,"description":79,"timeFrame":14},{"measure":82,"description":83,"timeFrame":12},"Measurement of strength in both shoulders_Lift off Test","Measurement of Strength: Lift off Test as Positive\u002FNegative\u002FUnable",{"measure":82,"description":83,"timeFrame":14},{"allocation":86,"interventionModel":87,"interventionModelDescription":88,"primaryPurpose":89,"observationalModel":88,"timePerspective":88,"maskingInfo":90},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":91,"maskingDescription":88,"whoMasked":88},"NONE",[93],{"label":94,"type":6,"description":95,"interventionNames":96},"total shoulder replacement surgery","Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery",[97],"Diagnostic Test: CT scan of the shoulders",[99],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"DIAGNOSTIC_TEST","CT scan of the shoulders","studies of both operative and nonoperative shoulders",[94],[105],"EMG of the shoulders",[107],{"name":108,"affiliation":5,"role":109},"April D Armstrong, MD","PRINCIPAL_INVESTIGATOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":115,"email":116},"Padmavathi Ponnuru, PhD","CONTACT","717-531-0003","284476","pponnuru@pennstatehealth.psu.edu",[118],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Penn State Hershey Medical Center","RECRUITING","Hershey","Pennsylvania","17033","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-76.65025,40.28592,{"lat":130,"lon":129},[133],{"name":134,"role":113,"phone":114,"phoneExt":115,"email":116},"Padmavathi Ponnuru, Ph.D.",{"type":109,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":138,"oldNameTitle":88,"oldOrganization":88},"April Armstrong","Professor of Surgery, Orthopaedics","Penn State Health Milton S Hershey Medical Center","100356510",false,"NCT03921944","Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty","Inclusion Criteria:\n\n* age \\>45yrs\n* primary diagnosis of osteoarthritis of the shoulder\n* total shoulder replacement performed by Dr. Armstrong\n* administered a local anesthetic mixture and not regional anesthesia\n* all genders\n* Fluent in written and spoken English\n* Patients capable of giving informed consent\n\nExclusion Criteria:\n\n* Known contraindications to CT\u002FEMG\n* Inability to provide informed consent\n* History of recent trauma to the shoulder\n* Atypical shoulder pain\n* Other suspected shoulder pathology (i.e. tumor, infection)\n* Pregnancy\n* Bilateral total shoulder arthroplasty","ALL","45 Years",{"count":147,"type":148},30,"ESTIMATED","INTERVENTIONAL",[86],"The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.",[153],"Osteoarthritis of Shoulder",[155,156,157],"shoulder surgery","arthritis","rotator cuff","2026-06-03",{"date":160,"type":161},"2026-06-05","ACTUAL",{"date":163,"type":161},"2024-05-02",{"date":165,"type":148},"2027-12",{"name":5,"class":6},1]