Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT04204135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-24
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Course of Hip Flexion Weakness Following LLIF or ALIF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip flexion and knee extension strength as measured by the Lafayette Instrument Manual Muscle Testing Device (Dynamometer).', 'timeFrame': 'Assessing changes in hip flexion and leg extension strength from the preoperative baseline to postoperative measurements taken at 6 weeks, 12 weeks and 6 months following lumbar fusions.', 'description': 'Using a Lafayette Instrument Manual Muscle Testing Device (Dynamometer), we will be measuring the force in pounds a given patient can exert upon hip flexion and knee extension at the preoperative timepoint and 6 weeks, 12 weeks and 6 months postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Herniated Nucleus Pulposus', 'Spondylolisthesis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the course of hip weakness after LLIF or ALIF procedures. These outcomes include measures of hip strength using a dynamometer, which is a device used to measure muscle strength. While it is known that people experience temporary hip and leg weakness after an LLIF or ALIF, the exact timing of when hip and leg strength is regained after an LLIF or ALIF is not known.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing LLIF or ALIF procedures', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-, 2-, or 3-level L2L3, L3L4, or L4L5 LLIF or ALIF for degenerative pathology including radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis, and scoliosis\n* Back and/or leg pain\n* Failed at least 6 months of conservative treatment\n\nExclusion Criteria:\n\n* Older than 65 years of age\n* Prior spinal fusion surgery\n* Greater than Grade 2 spondylolisthesis\n* Greater than 10° scoliosis\n* History of spinal infection'}, 'identificationModule': {'nctId': 'NCT04204135', 'briefTitle': 'The Course of Hip Flexion Weakness Following LLIF or ALIF', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'The Course of Hip Flexion Weakness Following LLIF or ALIF', 'orgStudyIdInfo': {'id': '16081205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LLIF or ALIF procedures', 'type': 'PROCEDURE', 'description': 'LLIF or ALIF procedures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}