Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00934869
Status:
UNKNOWN
Last Update Posted:
2013-03-22
First Post:
2009-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metacarpal Shaft Fractures']}, 'descriptionModule': {'briefSummary': 'Rotational deformity or malunion causes the most significant functional deficit in these common fractures. The evaluation of the rotation may be performed with the metacarpophalangeal joints flexed although postoperative swelling may not enable this examination with flexion of the fingers. Furthermore, it has been shown that swelling may cause rotation of the digit itself. The investigators propose that the swelling may cause a mistake in the estimation of rotation, during surgery and early follow up period. This is of special importance when open reduction and rigid fixation is performed.\n\nMethods:\n\nProspective analysis of XX isolated metacarpal fractures treated, in YY patients was performed. End-on view of the finger-nail was taken with a digital camera on the day of OR, at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand, according to the involved digit. Range of motion, type of fracture and type of fixation were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and Women with isolated metacarpal fractures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. isolated metacarpal fractures in one hand- fingers 2, 3, 4, 5\n2. treated with cast or surgical treatment , closed or open reduction\n\nExclusion Criteria:\n\n1. multiple fractures simultaneously\n2. fractures in both hands\n3. former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb)\n4. open fracture, open wounds, infection\n5. pregnancy, inability performing full x-ray follow up'}, 'identificationModule': {'nctId': 'NCT00934869', 'briefTitle': 'Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity', 'orgStudyIdInfo': {'id': 'LUR01-CTIL -HMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metacarpal Shaft Fractures'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'phone': '00 972 2 6776095'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Shai Luria, M.D', 'role': 'CONTACT', 'email': 'ShaiL@hadassah.org.il', 'phone': '972-2-6776342'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}}}}