Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT02435251
Status:
WITHDRAWN
Last Update Posted:
2019-10-23
First Post:
2015-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Anthropometry Following Ambulatory Orthopaedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'study was no longer feasible', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2015-04-27', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat mass', 'timeFrame': '6-weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Lean mass', 'timeFrame': '6-weeks after surgery'}, {'measure': 'Weight', 'timeFrame': '6-weeks after surgery'}, {'measure': 'Body mass index', 'timeFrame': '6-weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Surgery', 'Shoulder Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years-old\n* scheduled to undergo knee or shoulder ambulatory surgery\n\nExclusion Criteria:\n\n* weighs greater than 350 pounds\n* pregnancy\n* history of bariatric surgery\n* dieting or engaged in a weight loss program\n* taking weight loss supplements\n* undergoing other types of surgery during study period'}, 'identificationModule': {'nctId': 'NCT02435251', 'acronym': 'CAS', 'briefTitle': 'Changes in Anthropometry Following Ambulatory Orthopaedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Changes in Anthropometry Following Ambulatory Orthopaedic Surgery', 'orgStudyIdInfo': {'id': '458943-7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dual energy X-ray absorptiometry', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'UBMD Orthopaedics & Sports Medicine', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}], 'overallOfficials': [{'name': 'Leslie Bisson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'June A. & Eugene R. Mindell, MD Professor and Chair', 'investigatorFullName': 'Leslie Bisson', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}