Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-29 @ 3:36 PM
Study NCT ID:
NCT02945995
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome After Arthroscopic Surgery in Patients Treated With PAO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}], 'ancestors': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy', 'timeFrame': '48 months after hip arthroscopy', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the patients pain in rest and during activity on a NRS Scale', 'timeFrame': '48 months after hip arthroscopy', 'description': 'Questionnaire'}, {'measure': 'Evaluation of hip function and pain using MHHS (modified harris hip score)', 'timeFrame': '48 months after hip arthroscopy', 'description': 'Questionnaire'}, {'measure': 'Evaluation of hip function and pain using HOS (Hip outcome score)', 'timeFrame': '48 months after hip arthroscopy', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Developmental Dysplasia of the Hip']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy', 'detailedDescription': 'It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures.\n\nIn DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery\n\nThe investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing hip arthrocopy previous treated with periacetabular osteotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous PAO and hip arthroscopy\n* developmental dysplasia of the hip\n\nExclusion Criteria:\n\n* calve legg perthes disease\n* femoral osteotomy'}, 'identificationModule': {'nctId': 'NCT02945995', 'briefTitle': 'Outcome After Arthroscopic Surgery in Patients Treated With PAO', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Outcome After Arthroscopic Labrum Surgery in Patients Treated With Periacetabular Osteotomy', 'orgStudyIdInfo': {'id': 'CHA-PostPAO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hip arthroscopy', 'type': 'PROCEDURE', 'description': 'Follow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin Lind, MD,PhD,DmSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Martin Lind', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}