Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
Study NCT ID:
NCT06876350
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562760', 'term': 'Capillary Malformations, Congenital, 1'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction Score', 'timeFrame': '6 Weeks', 'description': 'The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Waste', 'timeFrame': '2 Weeks', 'description': 'Each splint group creates waste for the fabrication and molding for each patient which will be recorded by the clinical research coordinator and weighed out.'}, {'measure': 'Splint Satisfaction', 'timeFrame': '6 Weeks', 'description': 'Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.'}, {'measure': 'Splint Issues', 'timeFrame': '6 Weeks', 'description': 'A single question will be filled out by patients on a scale of 1-5 with a score of 5 indicating a lot of issues with their splint.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized', 'Hand and Upper Extremity'], 'conditions': ['Carpometacarpal (CMC) Joint Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.', 'detailedDescription': 'Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 years old.\n* Intact Medical Decision Making\n* Eligible for Surgical Intervention\n* Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks\n\nExclusion Criteria:\n\n* Pregnant Women\n* Deemed Unsuitable by Principal Investigator'}, 'identificationModule': {'nctId': 'NCT06876350', 'acronym': 'Woodcast', 'briefTitle': 'Woodcasting Versus Thermoplast Splint in CMC Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Orthopaedic Research and Education'}, 'officialTitle': 'Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint', 'orgStudyIdInfo': {'id': 'Study007574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Woodcasting Splint', 'description': 'Woodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes.', 'interventionNames': ['Other: Woodcasting Splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thermoplastic Splint', 'description': 'Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty.', 'interventionNames': ['Other: Control (Standard treatment)']}], 'interventions': [{'name': 'Woodcasting Splint', 'type': 'OTHER', 'description': 'This is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores', 'armGroupLabels': ['Woodcasting Splint']}, {'name': 'Control (Standard treatment)', 'type': 'OTHER', 'description': 'Thermoplastic splints are standard of care treatment for patients after CMC arthroplasty. We will use the data from this group as the comparator to the experimental group.', 'armGroupLabels': ['Thermoplastic Splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andy Nguyen, BS', 'role': 'CONTACT', 'email': 'anguyen@foreonline.org', 'phone': '8139789700', 'phoneExt': '6837'}, {'name': 'Michael Doarn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alfred Hess, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronald Mitchell, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Andy Nguyen, BS', 'role': 'CONTACT', 'email': 'anguyen@foreonline.org', 'phone': '8139789700', 'phoneExt': '6837'}, {'name': 'Deborah Warren, RN', 'role': 'CONTACT', 'email': 'dwarren@foreonline.org', 'phone': '8139789700'}], 'overallOfficials': [{'name': 'Michael Doarn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Each participant data will be grouped for each cohort and averaged, so individual participant data is not necessary to perform a data analysis of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Orthopaedic Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael C. Doarn', 'investigatorAffiliation': 'Foundation for Orthopaedic Research and Education'}}}}