Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04875156
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'measurement of the joint mobility and the force of the thumb'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pinch strength of the thumb (in kilograms force)', 'timeFrame': '10 minutes', 'description': 'pinch strength of the thumb in key-pinch, opposition-pinch and tripod-pinch'}, {'measure': 'the angle of the metacarpophalangeal joint of the thumb (in degrees)', 'timeFrame': '10 minutes', 'description': 'the angle of the metacarpophalangeal joint of the thumb (in degrees) during maximal force in the three pinch positions'}, {'measure': 'range of motion of the metacarpophalangeal joint of the thumb (in degrees)', 'timeFrame': '10 minutes', 'description': 'range of motion of the metacarpophalangeal joint of the thumb (in degrees) measuring maximal flexion and maximal extension of the joint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-traumatic; Arthrosis', 'Osteoarthritis Thumb']}, 'referencesModule': {'references': [{'pmid': '37401127', 'type': 'DERIVED', 'citation': 'Gryson T, Van Der Velde G, Hollevoet N. Metacarpophalangeal joint angle of the thumb during maximal pinch strength: a study of healthy volunteers. J Hand Surg Eur Vol. 2023 Dec;48(11):1229-1230. doi: 10.1177/17531934231184821. Epub 2023 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to measure the position of the metacarpophalangeal joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.', 'detailedDescription': 'The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.\n\nThe force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch). Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP joint of the thumb in maximum flexion and extension will also be measured. A total of about 300 healthy volunteers will be examined, with no history of trauma or disease to tendons or joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and health sciences will be part of the research team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 40 years\n\nExclusion Criteria:\n\n* (previous) pathology of the joints, ligaments or tendons of the thumb'}, 'identificationModule': {'nctId': 'NCT04875156', 'briefTitle': 'The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength: Implications for Arthrodesis', 'orgStudyIdInfo': {'id': 'BC-08063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'normal volunteers', 'description': 'normal volunteers between 18 and 40 years old, men and women. Measurement of the range of motion of the metacarpophalangeal joint with a goniometer and pinch strength of the thumb with a dynamometer', 'interventionNames': ['Other: measurement of range of motion and strength']}], 'interventions': [{'name': 'measurement of range of motion and strength', 'type': 'OTHER', 'description': 'measurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb', 'armGroupLabels': ['normal volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Nadine I Hollevoet, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}