Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-28 @ 12:36 PM
Study NCT ID:
NCT03716661
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operative vs. Conservative Treatment of Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related complications at baseline', 'timeFrame': 'Baseline'}, {'measure': 'Change in number of participants with treatment-related complications from baseline at week 2', 'timeFrame': 'Week 2'}, {'measure': 'Change in number of participants with treatment-related complications from baseline at week 5', 'timeFrame': 'Week 5'}, {'measure': 'Change in number of participants with treatment-related complications from baseline at month 6', 'timeFrame': 'Month 6'}, {'measure': 'Change in number of participants with treatment-related complications from baseline at 1 year', 'timeFrame': '1 Year'}, {'measure': 'Range of motion of the wrist at week 5', 'timeFrame': 'Week 5', 'description': 'a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)'}, {'measure': 'Change in range of motion of the wrist from week 5 at month 6', 'timeFrame': 'Month 6', 'description': 'a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)'}, {'measure': 'Change in range of motion of the wrist from month 6 at 1 year', 'timeFrame': '1 Year', 'description': 'a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)'}, {'measure': 'Level of functioning at baseline', 'timeFrame': 'Baseline', 'description': 'Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)'}, {'measure': 'Change in level of functioning from baseline at week 2', 'timeFrame': 'Week 2', 'description': 'Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)'}, {'measure': 'Change in level of functioning from baseline at week 5', 'timeFrame': 'Week 5', 'description': 'Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)'}, {'measure': 'Change in level of functioning from baseline at month 6', 'timeFrame': 'Month 6', 'description': 'Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)'}, {'measure': 'Change in level of functioning from baseline at 1 year', 'timeFrame': '1 Year', 'description': 'Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radius Distal Fracture', 'Distal Radius Fracture', 'Radius Fracture Distal']}, 'referencesModule': {'references': [{'pmid': '36902861', 'type': 'DERIVED', 'citation': 'Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. Prospective Evaluation of Two Cohorts of Non-Operatively Treated Patients with Displaced vs. Minimally and Non-Displaced Distal Radius Fractures. J Clin Med. 2023 Mar 6;12(5):2076. doi: 10.3390/jcm12052076.'}, {'pmid': '36443579', 'type': 'DERIVED', 'citation': 'Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years. J Orthop Traumatol. 2022 Nov 28;23(1):54. doi: 10.1186/s10195-022-00673-4.'}, {'pmid': '31253145', 'type': 'DERIVED', 'citation': 'Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.'}]}, 'descriptionModule': {'briefSummary': 'Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish National Guidelines for operative treatment of distal radius fractures\n\nExclusion Criteria:\n\n* Patients treated with plaster in Arm1/control group who unexpectedly requires surgery'}, 'identificationModule': {'nctId': 'NCT03716661', 'briefTitle': 'Operative vs. Conservative Treatment of Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Operative vs. Conservative Treatment of Distal Radius Fractures', 'orgStudyIdInfo': {'id': '1-10-72-420-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines.'}, {'type': 'NO_INTERVENTION', 'label': 'Conservative', 'description': 'Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines.\n\nArm 2: Patients randomized to conservative plaster treatment'}, {'type': 'OTHER', 'label': 'Operative', 'description': 'Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines.\n\nArm 3: Patients randomized to operative treatment (ORIF)', 'interventionNames': ['Procedure: ORIF']}], 'interventions': [{'name': 'ORIF', 'type': 'PROCEDURE', 'description': 'Open Reduction Internal Fixation', 'armGroupLabels': ['Operative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Regionshospitalet Randers', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}