Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-20 @ 7:21 AM
Study NCT ID:
NCT03623269
Status:
UNKNOWN
Last Update Posted:
2019-05-30
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Approach to Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recovery', 'timeFrame': 'preoperative to 6 months postoperatively', 'description': 'American shoulder and elbow score (ASES) with a range from 0-100, with 0 being worst outcome and 100 being best outcome'}, {'measure': 'recovery', 'timeFrame': 'preoperative to 6 months postoperatively', 'description': 'Simple Shoulder Test score (SST) with a range from 0-12 with 12 being the best score and 0 being the worst score.'}, {'measure': 'recovery', 'timeFrame': 'preoperative to 6 months postoperatively', 'description': 'range of motion'}, {'measure': 'complications', 'timeFrame': '6 months postoperative', 'description': 'percent of complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Shoulder Arthroplasty', 'Osteo Arthritis Shoulders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients of the principal investigator receiving the posterior approach to total shoulder arthroplasty for any indication at our institution between September 1, 2016 and October 31, 2017 were evaluated and included in the data analysis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English speaking\n2. \\>18 years of age\n3. Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. \\<18 years of age\n3. Loose bone in the anterior recess of the shoulder\n4. Severe arthritis with significant bony deformity'}, 'identificationModule': {'nctId': 'NCT03623269', 'acronym': 'pTSA', 'briefTitle': 'Posterior Approach to Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Orthopaedic Research & Innovation Foundation'}, 'officialTitle': 'Posterior Approach to Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing the Posterior Approach to Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'ORIF.005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'posterior approach to total shoulder arthroplasty', 'type': 'PROCEDURE', 'description': 'The posterior approach to total shoulder arthroplasty approaches the patient from the back of the shoulder and spares the rotator cuff.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Orthopaedic Research & Innovation Foundation', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}], 'overallOfficials': [{'name': 'R M Greiwe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Orthopaedic Research & Innovation Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Orthopaedic Research & Innovation Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}