Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 12:02 PM
Study NCT ID:
NCT03996512
Status:
WITHDRAWN
Last Update Posted:
2021-06-25
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Recruitment issues. Inclusion Criteria was strict due to the experimental nature of intervention', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional outcome range of motion', 'timeFrame': 'at entry and up to 12 months', 'description': 'Using a goniometer measuring the angle of wrist flexion and extension\n\nNEED TO ENTER EXPECTED ROM ranges'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scaphoid Fixation']}, 'descriptionModule': {'briefSummary': 'There is poor research supporting the benefits of Early Active Controlled Motion (EACM) protocols post operative scaphoid fixation. Advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. The study uses a pre-experimental design with purposeful sample population recruitment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Date of injury and diagnosis: scaphoid fracture less than 3 weeks old\n* Waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone.\n* Surgical procedure includes ORIF with screw fixation and/or percutaneous pin with screw fixation.\n* To be included in the study the patient needs to have started rehab within the first 10 days after surgery date.\n\nExclusion Criteria:\n\n* Proximal pole scaphoid fracture\n* Past medical history of diabetes and other peripheral vascular disorders.\n* History of osteopenia and osteoporosis.\n* Previously failed ORIF of scaphoid\n* Neurovascular or nerve lesion to the involved upper extremity\n* Cognitive deficits related to memory, attention span, judgment as documented in the EMR or need for a legal guardian to be a medical proxy'}, 'identificationModule': {'nctId': 'NCT03996512', 'briefTitle': 'Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB201900006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post scaphoid fracture with screw fixation', 'description': 'Post surgical rehabilitation using an early active controlled wrist motion rehab protocol that limits the amount of proximal carpal row loading forces', 'interventionNames': ['Other: Early Active Controlled Motion (EACM)']}], 'interventions': [{'name': 'Early Active Controlled Motion (EACM)', 'type': 'OTHER', 'description': 'Early active controlled wrist motion rehab protocol using that will allow midcarpal row motion.', 'armGroupLabels': ['Post scaphoid fracture with screw fixation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sarah Mersch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Performance Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}