Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07357493
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
metaCARpal Bone Osteosynthesis Trail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 552}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grip strength', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'The primary outcome is grip-strength measured in the injured hand using a JAMAR dynamometer at 12 months and presented in kilograms. Measurement method will follow the technical description presented in the HAKIR manual (HAKIR, 2023).'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'infection, malunion, nerve injury, reoperation'}, {'measure': 'Pain in injured hand NRS', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'NRS (Numerical Rating Scale) at rest and when it is at its worst'}, {'measure': 'Rotational deformity', 'timeFrame': '12 months', 'description': '0 - no deformity, 1 - minimal deformity, 2 - clearly visible deformity but acceptable functional limitation, 3 - great deformity and functional limitation'}, {'measure': 'PROM - patient rated outcome measure', 'timeFrame': '6, 12 weeks, 12 months', 'description': 'Quick-DASH-9 score (Gabel et al., 2009)'}, {'measure': 'Range of motion', 'timeFrame': '6, 12 weeks, 12 months', 'description': 'total active motion and extension lag'}, {'measure': 'Pinch grip strength', 'timeFrame': '12 weeks, 12 months'}, {'measure': 'Radiographic shortening', 'timeFrame': '12 months', 'description': 'according to Sletten (Sletten et al., 2013)'}, {'measure': 'Radiographic healing', 'timeFrame': '12 weeks, 12 months', 'description': 'defined as bridging callus formation over the fracture line on a plain x-ray anterio-posterior and/or lateral projection. (Hayes et al., 2023)'}, {'measure': 'Sick leave duration', 'timeFrame': '12 months', 'description': 'in days'}, {'measure': 'Patient satisfaction', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'Patient Acceptable Symptom State, PASS (Daryoush et al., 2025)'}, {'measure': 'Quality of life measured by PROM', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'EQ-5D EuroQol Group, 1990; Taft et al., 2004)'}, {'measure': 'Quality of life measured by SF-12', 'timeFrame': 'From enrollment to the end of follow-up at 12 months', 'description': 'SF-12 (EuroQol Group, 1990; Taft et al., 2004)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-operative', 'operative', 'metacarpal', 'shaft', 'displaced', 'mobilization'], 'conditions': ['Metacarpal Shaft Fractures']}, 'descriptionModule': {'briefSummary': 'Background Metacarpal shaft fractures account for 30-50% of hand fractures (Karl et al., 2015; Kollitz et al., 2014; van Onselen et al., 2003), with diaphyseal spiral and oblique fractures of the second to fifth ray posing unique challenges due to the risks of shortening and rotational deformities. Current standard care of displaced fractures involves operative fixation.\n\nHowever, retrospective studies have indicated that nonoperative treatment, involving early mobilization or buddy taping, can achieve outcomes comparable to operative treatment (Daher et al., 2023). There is only one published, with a small sample size, randomized controlled trial (RCT) investigating this issue (Peyronson et al., 2023). This highlights the need for a robust multicenter RCT to address these gaps in evidence.\n\nAim The aim of this study is to compare the one-year outcomes of non-operative treatment involving immediate unrestricted mobilization versus operative treatment of displaced oblique or spiral diaphyseal metacarpal fractures in adults.\n\nMaterials and Methods This is a multicenter, pragmatic, prospective, noninferiority RCT involving 552 adult patients with displaced oblique and/or spiral diaphyseal metacarpal fractures of the second to fifth ray. Participants will be randomized 1:1 to receive either nonoperative treatment with unrestricted mobilization and rehabilitation) or operative treatment (with screw or plate fixation) followed by rehabilitation.\n\nThe primary outcome is grip-strength in the injured hand presented in kilograms at one year.\n\nSecondary outcomes include questionnaires, complications, range of motion, patient reported outcome measures, health related quality of life, patient satisfaction, and radiographic healing.\n\nA power calculation proposes a study size of 552 participants to detect a noninferiority margin of 10% in grip strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Access to a valid e-mail.\n* Injury within 10 days prior to inclusion.\n* Normal bilateral hand function prior to injury.\n* Ability and willingness to provide written informed consent\n* Single, displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals with definition of diaphysis as described by AO 2018 (AO/OTA as 77.2-5.2A) (Meinberg et al., 2018).\n* Fracture line length at least twice the diameter of the bone at the level of the fracture.\n* Fractures with at least 2 mm of radiological displacement and/or malrotation of injured finger compared to uninjured side regardless of fracture displacement.\n\nExclusion Criteria:\n\n* The patient IS NOT expected to have difficulty adhering to the study protocol (e.g., due to insufficient language proficiency, dementia, substance abuse, or other reasons).\n* The patient DOES NOT have an open fracture (Gustilo-Anderson grade \\> I) or a pathological fracture.\n* The patient DOES NOT have an ipsilateral fracture of the upper extremity, polytrauma, or generalized joint dysfunction (e.g., rheumatoid arthritis).'}, 'identificationModule': {'nctId': 'NCT07357493', 'acronym': 'CARBO', 'briefTitle': 'metaCARpal Bone Osteosynthesis Trail', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The CARBO Study (metaCARpal Bone Osteosynthesis)', 'orgStudyIdInfo': {'id': '2025-04413-01'}, 'secondaryIdInfos': [{'id': 'FoUI-1022484', 'type': 'OTHER_GRANT', 'domain': 'ALF Region Stockholm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-operative with early mobilization', 'description': 'Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff.', 'interventionNames': ['Procedure: Non-operative treatment with early mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Operative', 'description': "Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation.", 'interventionNames': ['Procedure: Operative treatment']}], 'interventions': [{'name': 'Non-operative treatment with early mobilization', 'type': 'PROCEDURE', 'description': 'Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff.', 'armGroupLabels': ['Non-operative with early mobilization']}, {'name': 'Operative treatment', 'type': 'PROCEDURE', 'description': "Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation.", 'armGroupLabels': ['Operative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Cecilia Mellstrand Navarro, MD, Ass Professor', 'role': 'CONTACT', 'email': 'cecilia.mellstrand.navarro@ki.se', 'phone': '+46 709 280114'}, {'name': 'Elsa Pihl, MD, PhD', 'role': 'CONTACT', 'email': 'elsa.pihl@ki.se', 'phone': '+46739705669'}, {'name': 'Cecilia Mellstrand Navarro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elsa Pihl, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Karolinska Institutet, Danderyd's hospital", 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Cecilia Mellstrand Navarro, Associate professor', 'role': 'CONTACT', 'email': 'cecilia.mellstrand.navarro@ki.se', 'phone': '+46709280114'}, {'name': 'Elsa Pihl, PhD', 'role': 'CONTACT', 'email': 'elsa.pihl@ki.se', 'phone': '+46739705669'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data on group level will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Umeå University', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Københavns Universitet', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Östersund Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Cecilia Mellstrand Navarro', 'investigatorAffiliation': 'Karolinska Institutet'}}}}