Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT01763359
Status:
TERMINATED
Last Update Posted:
2020-05-04
First Post:
2013-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2013-01-04', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls).', 'timeFrame': '1 year follow-up after surgery'}], 'secondaryOutcomes': [{'measure': 'Radiographs and clinical assessment at follow-up appointments will be used to determine incidence of obturator nerve palsy in both groups (subjects and controls).', 'timeFrame': '1 year follow-up after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acetabular fracture', 'pelvic fracture', 'hip adductor strength', 'obturator nerve palsy', 'modified Stoppa approach'], 'conditions': ['Acetabular Fracture', 'Pelvic Fracture']}, 'descriptionModule': {'briefSummary': "The purpose of this prospective study is to compare hip adductor strength and obturator nerve palsy between acetabular fracture patients whose fracture was reduced and fixated using the modified Stoppa approach (subjects) and pelvic fracture patients (controls) using physical strength testing, radiographs, clinical assessment, and a validated functional outcome questionnaire. The investigators' research hypothesis is that there will be less strength and higher incidence of obturator nerve palsy in patients treated with the modified Stoppa approach (intervention) than in patients treated without the modified Stoppa approach (controls)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pelvic fracture patients and patients treated for acetabular fractures with the modified Stoppa approach will be asked to consent to a voluntary study investigating physical function at their 2 week follow-up appointment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for the subject patient population under study consists of male and female adults, at least 18 years old, who had an acetabular fracture that was treated with the modified Stoppa approach.\n* Inclusion criteria for the control patient population under study consists of male and female adults, at least 18 years old, who had acetabular fractures with similar fracture patterns as the study group that were treated with any other approach than the Stoppa approach.\n\nExclusion Criteria:\n\n* Exclusion criteria for the subject and control patient population consist of:\n* Patients who are non-ambulatory.\n* Patients less than 18 years of age.\n* Patients who do not speak English.\n* Patients who are unable to complete their follow-up in Utah.'}, 'identificationModule': {'nctId': 'NCT01763359', 'briefTitle': 'Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Decreased Hip Adductor Strength and Obturator Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation: Is Retraction to Blame?', 'orgStudyIdInfo': {'id': '55695'}}, 'contactsLocationsModule': {'locations': [{'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopedics Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David Rothberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Surgery Operations'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'David Rothberg', 'investigatorAffiliation': 'University of Utah'}}}}