Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-06 @ 6:07 PM
Study NCT ID:
NCT03248934
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Performed Examination for Patients With Intra-articular Hip Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'End of clinician examination, 20 minutes', 'description': "As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive)."}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': 'End of clinician examination, 20 minutes', 'description': 'As measured by the discriminatory ability of the diagnostic test to identify if the disease or condition is absent when in actuality it is truly absent (i.e. true negative).'}, {'measure': 'Diagnostic accuracy measure of positive likelihood ratio', 'timeFrame': 'End of clinician examination, 20 minutes', 'description': 'As measured by sensitivity and specificity values.'}, {'measure': 'Diagnostic accuracy measure of negative likelihood ratio', 'timeFrame': 'End of clinician examination, 20 minutes', 'description': 'As measured by sensitivity and specificity values.'}, {'measure': 'Diagnostic accuracy measure of post-test probabilities', 'timeFrame': 'End of clinician examination, 20 minutes', 'description': 'As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Pain Chronic', 'Hip Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80 years\n* Seeking care for hip related pain and/or clicking, catching, giving way or stiffness\n* Able to sign or verbalize study consent\n* No other medical conditions (e.g. gynecological or urinary pathology) that may affect study results\n* English speaking\n\nExclusion Criteria:\n\n* Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination\n* Previous hip surgery\n* Previous hip injury that would normally exclude from examination as standard practice\n* Unable to sign or verbalize consent\n* Other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology)\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03248934', 'briefTitle': 'Patient Performed Examination for Patients With Intra-articular Hip Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Delineating the Concurrent Validity and Diagnostic Accuracy of a Patient Performed Examination for Patients With Intra-Articular Hip Pain: A Proof of Concept Study', 'orgStudyIdInfo': {'id': 'Pro00082395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Self-Administered Exam Group', 'description': 'Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam.', 'interventionNames': ['Other: Patient Self-Administered Diagnostic Exam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinician-Performed Exam Group', 'description': 'Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam.', 'interventionNames': ['Other: Clinician-Performed Diagnostic Exam']}], 'interventions': [{'name': 'Patient Self-Administered Diagnostic Exam', 'type': 'OTHER', 'description': 'Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.', 'armGroupLabels': ['Patient Self-Administered Exam Group']}, {'name': 'Clinician-Performed Diagnostic Exam', 'type': 'OTHER', 'description': 'A clinician-performed diagnostic exam will be completed on the patients.', 'armGroupLabels': ['Clinician-Performed Exam Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Richard C. Mather', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}