Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 7:58 PM
Study NCT ID:
NCT04668794
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2020-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carpometacarpal Fracture-dislocations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'C119975', 'term': 'POLR1G protein, human'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamate fracture', 'timeFrame': '6 months', 'description': 'Hamate fracture associated with the dislocation of the fifth and fourth finger. Cain´s classification for the description of fracture-dislocation. Milch´s classification for hamate fractures types.'}, {'measure': 'Degree of displacement', 'timeFrame': '6 months', 'description': 'Degree of displacement (% displacement) in X-rays and CT scan.'}, {'measure': 'Intrarticular stepoff and degenerative osteoarthritis', 'timeFrame': '6 months', 'description': 'Intrarticular stepoff (mm) and sclerosis, cysts, osteophytes, joint space reduction (mm) in X-rays and CT scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpometacarpal; Dislocation']}, 'referencesModule': {'references': [{'pmid': '25637730', 'type': 'RESULT', 'citation': 'Kural C, Basaran SH, Ercin E, Bayrak A, Bilgili MG, Baca E. Fourth and fifth carpometacarpal fracture dislocations. Acta Orthop Traumatol Turc. 2014;48(6):655-60. doi: 10.3944/AOTT.2014.14.0040.'}, {'pmid': '25538072', 'type': 'RESULT', 'citation': 'Gehrmann SV, Kaufmann RA, Grassmann JP, Logters T, Schadel-Hopfner M, Hakimi M, Windolf J. Fracture-dislocations of the carpometacarpal joints of the ring and little finger. J Hand Surg Eur Vol. 2015 Jan;40(1):84-7. doi: 10.1177/1753193414562706.'}, {'pmid': '3958446', 'type': 'RESULT', 'citation': 'Mueller JJ. Carpometacarpal dislocations: report of five cases and review of the literature. J Hand Surg Am. 1986 Mar;11(2):184-8. doi: 10.1016/s0363-5023(86)80048-x.'}, {'pmid': '3818751', 'type': 'RESULT', 'citation': 'Henderson JJ, Arafa MA. Carpometacarpal dislocation. An easily missed diagnosis. J Bone Joint Surg Br. 1987 Mar;69(2):212-4. doi: 10.1302/0301-620X.69B2.3818751.'}, {'pmid': '1588193', 'type': 'RESULT', 'citation': 'Kjaer-Petersen K, Jurik AG, Petersen LK. Intra-articular fractures at the base of the fifth metacarpal. A clinical and radiographical study of 64 cases. J Hand Surg Br. 1992 Apr;17(2):144-7. doi: 10.1016/0266-7681(92)90075-d.'}, {'pmid': '29411672', 'type': 'RESULT', 'citation': 'Cobb WA, Dingle L, Zarb Adami R, Rodrigues J. Management of fracture-dislocations of the little finger carpometacarpal joint: a systematic review. J Hand Surg Eur Vol. 2018 Jun;43(5):530-538. doi: 10.1177/1753193417752317. Epub 2018 Feb 7.'}, {'pmid': '23204970', 'type': 'RESULT', 'citation': 'Storken G, Bogie R, Jansen EJ. Acute ulnar carpometacarpal dislocations. Can it be treated conservatively? A review of four cases. Hand (N Y). 2011 Dec;6(4):420-3. doi: 10.1007/s11552-011-9347-3. Epub 2011 Jul 7. No abstract available.'}, {'pmid': '6600352', 'type': 'RESULT', 'citation': 'Fisher MR, Rogers LF, Hendrix RW. Systematic approach to identifying fourth and fifth carpometacarpal joint dislocations. AJR Am J Roentgenol. 1983 Feb;140(2):319-24. doi: 10.2214/ajr.140.2.319.'}, {'pmid': '17331628', 'type': 'RESULT', 'citation': "Hodgson PD, Shewring DJ. The 'metacarpal cascade lines'; use in the diagnosis of dislocations of the carpometacarpal joints. J Hand Surg Eur Vol. 2007 Jun;32(3):277-81. doi: 10.1016/J.JHSB.2006.09.020."}, {'pmid': '37227483', 'type': 'DERIVED', 'citation': 'Fa-Binefa M, Almenara M, Mata-Munoz JM, Gich-Saladich I, Llauger J, Lamas C. Retrospective interobserver agreement on diagnoses of 4th and 5th carpometacarpal fracture-dislocation and hamate fracture in plain X-ray - Is CT essential after ulnar carpometacarpal pain? Skeletal Radiol. 2023 Dec;52(12):2427-2433. doi: 10.1007/s00256-023-04366-9. Epub 2023 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Fracture-dislocation of the CMC joints of the ring and little finger are extremely mobile because of their saddle shape anatomy and loose ligamentous attachments. Missed and incorrect diagnosis is very frequent in metacarpal base injuries of the hand and results in impaired function and weak grip. In these lesions immediate reduction is imperative. Treatment options for these injuries include non-operative management, closed reduction with Kirschner wire fixation (K-wire) and open reduction with internal fixation (ORIF). In chronic CMC fracture-dislocations ORIF is mandatory. Although operative treatment is recommended in the literature in fracture-dislocation of the CMC joints of the ring and little finger, other authors, in specific cases, performed conservative treatment through immediate reduction and splint immobilization and this treatment can be sufficient.', 'detailedDescription': 'Physical examination in carpometacarpal injuries reveals ulnar-sided pain, swelling, diffuse edema, a palpable lump and tenderness of the hand.\n\nRadiological examination include hand-wrist radiographs in the posteroanterior (PA), true lateral and 45º oblique views. A true lateral view of the hand may demonstrate the dislocation, although overlapping of the joints can mask the dislocation. On PA radiographs, Fisher et al. propose using the so-called M-line parallelism of the CMC joints. A break in this M-line suggests a dislocation. Another method is to draw metacarpal cascade lines on a PA radiographs.\n\nIt is important to recognise the associate lesions, for example hamate fractures, because this fracture can change the prognosis, surgical planning and treatment. The investigators hypothesized that there is an interobserver variability to evaluate the carpometacarpal fracture-dislocation and associated lesions in x-rays are underestimated. The investigators propose a protocol with a CT scan to asses this lesions. The researchers hypothesised that surgical reconstruction would result in better clinical result and lower complications rate than non-surgical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients are adults with a closed injury in their hand. For clinical, x-ray and TC we evaluated the carpometacarpal fracture dislocation of the hand and associated lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Closed carpometacarpal fracture dislocation of the hand\n* Adults from 18 to 80 years old\n\nExclusion Criteria:\n\n* history of fractures or tendon lesions in the same hand\n* Children\n* Open fracture dislocations'}, 'identificationModule': {'nctId': 'NCT04668794', 'acronym': 'Dislocation', 'briefTitle': 'Carpometacarpal Fracture-dislocations', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Carpometacarpal Fracture-dislocation of the Hand: Interobserver and Intraobserver Variability for Identify Associate Hamate Fractures and Its Implications in Surgical Planning and Treatment', 'orgStudyIdInfo': {'id': 'IIBSP-FLC-2020-29'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['Cast'], 'description': 'Reduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Claudia Lamas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Retrospective study that observe the x-rays and TC scan and the results of the surgical or conservative treatment.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}