Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:25 AM
Study NCT ID:
NCT07410650
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-13
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subscapularis-Sparing Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': 'Pre-operative', 'description': 'Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.'}, {'measure': 'Patient-reported outcome (Simple Shoulder Test (SST))', 'timeFrame': 'Pre-operative', 'description': 'There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.'}, {'measure': 'Patient-reported outcome (Visual Analogue Score (VAS))', 'timeFrame': 'Pre-operative', 'description': 'VAS pain score (0 no pain - 10 severe pain)'}, {'measure': 'Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': '6-weeks post-operative', 'description': 'Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.'}, {'measure': 'Patient-reported outcome (Simple Shoulder Test (SST))', 'timeFrame': '6-weeks post-operative', 'description': 'There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.'}, {'measure': 'Patient-reported outcome (Visual Analogue Score (VAS))', 'timeFrame': '6-weeks post-operative', 'description': 'VAS pain score (0 no pain - 10 severe pain)'}, {'measure': 'Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': '3-months post-operative', 'description': 'Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.'}, {'measure': 'Patient-reported outcome (Simple Shoulder Test (SST))', 'timeFrame': '3-months post-operative', 'description': 'There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.'}, {'measure': 'Patient-reported outcome (Visual Analogue Score (VAS))', 'timeFrame': '3-months post-operative', 'description': 'VAS pain score (0 no pain - 10 severe pain)'}, {'measure': 'Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': '1-year post-operative', 'description': 'Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.'}, {'measure': 'Patient-reported outcome (Simple Shoulder Test (SST))', 'timeFrame': '1-year post-operative', 'description': 'There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.'}, {'measure': 'Patient-reported outcome (Visual Analogue Score (VAS))', 'timeFrame': '1-year post-operative', 'description': 'VAS pain score (0 no pain - 10 severe pain)'}, {'measure': 'Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': '2-years post-operative', 'description': 'Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.'}, {'measure': 'Patient-reported outcome (Simple Shoulder Test (SST))', 'timeFrame': '2-years post-operative', 'description': 'There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.'}, {'measure': 'Patient-reported outcome (Visual Analogue Score (VAS))', 'timeFrame': '2-years post-operative', 'description': 'VAS pain score (0 no pain - 10 severe pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glenohumeral Osteoarthritis', 'Total Shoulder Arthroplasty', 'Subscapularis-Sparing', 'Prospective Study', 'Patient-Reported Outcomes'], 'conditions': ['Total Shoulder Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The investigators purpose of this study are to perform a prospective clinical study to determine the following after subscapularis-sparing anatomic total shoulder arthroplasty performed for glenohumeral osteoarthritis:\n\n1. patient-reported outcomes\n2. shoulder motion and strength\n3. rotator cuff integrity\n4. the accuracy of component placement and the completeness of osteophyte removal', 'detailedDescription': 'Anatomic total shoulder arthroplasty (TSA) provides excellent pain relief and restoration of shoulder function in the setting of glenohumeral osteoarthritis. However, the surgical approach requires the subscapularis to be cut and repaired, via either a lesser tuberosity osteotomy, a subscapularis tenotomy, or a subscapularis peel.This repair must be protected post-operatively, even with a lesser tuberosity osteotomy, or it can displace or fail to heal, which complicates rehabilitation. Failure of the subscapularis repair occurs in 10-25% of patients. Failure of the subscapularis repair is often devastating for shoulder function and often requires revision to a reverse total shoulder arthroplasty. Even when muscle-tendon-bone healing does occur there is post-operative atrophy of the subscapularis that may compromise function and strength. Atrophy of the subscapularis may lead to imbalance of the rotator cuff musculature, leading to subluxation and glenoid loosening. While there have been attempts to develop approaches that do not involve cutting the subscapularis, they have been plagued by osteophyte retention, component malposition, damage to the deltoid, or damage to the supraspinatus.\n\nThe principal investigator has spent four years developing a technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons and has been through the learning curve with this technique by completing \\>20 cases and at least as many cadaver surgeries during that time period. This technique has been designed to avoid the potential issues with prior attempts and utilizes purpose designed instrumentation and retractors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.\n\nExclusion Criteria:\n\n* Patients unwilling to consent and comply with study procedures (i.e. follow up visits).\n* Patients under the age of 18.\n* Patients with contraindications to an anatomic total shoulder arthroplasty such as active infection, insufficient glenoid bone, damage to the rotator cuff, or a history of instability.\n* Patients with known prior shoulder arthroplasty.\n* Patients unable to undergo a magnetic resonance imaging study.'}, 'identificationModule': {'nctId': 'NCT07410650', 'briefTitle': 'Subscapularis-Sparing Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study', 'orgStudyIdInfo': {'id': '137991'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Subscapularis-Sparing Total Shoulder Arthroplasty', 'type': 'PROCEDURE', 'description': 'A surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopedics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Peter Chalmers, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Peter Chalmers', 'investigatorAffiliation': 'University of Utah'}}}}