Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT01396694
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2011-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2011-07-17', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '3 months', 'description': 'Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': '3 months', 'description': 'Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychological Predictors']}, 'descriptionModule': {'briefSummary': 'All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 yrs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* require arthroscopy or arthroplasty\n\nExclusion Criteria:\n\n* age less than 18 yrs\n* prior surgery\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01396694', 'briefTitle': 'An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction', 'orgStudyIdInfo': {'id': 'IRB00061869'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all', 'description': 'All patients requiring arthroscopy or arthroplasty', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire', 'armGroupLabels': ['all']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS', 'investigatorAffiliation': 'Emory University'}}}}