Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT05015556
Status:
UNKNOWN
Last Update Posted:
2022-10-05
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial 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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding of results by computer of the outcome results. Blinding of the patients or the care provider is not possible due to the obvious differences.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-08-14', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QALY', 'timeFrame': '1 year', 'description': 'Using the Short Form 36 (SF-36) assessment - cost effectiveness (The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.)'}, {'measure': 'Costs', 'timeFrame': '1 year', 'description': 'Direct, indirect, health insurances'}], 'secondaryOutcomes': [{'measure': 'Wrist ROM', 'timeFrame': '1 year', 'description': 'Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)'}, {'measure': 'Grip Strength', 'timeFrame': '1 year', 'description': 'Using the Jamar grip dynamometer'}, {'measure': 'VAS', 'timeFrame': '1 year', 'description': 'Pain using the VAS (0-10)'}, {'measure': 'DASH', 'timeFrame': '1 year', 'description': 'Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)'}, {'measure': 'PRWE', 'timeFrame': '1 year', 'description': 'Patient rated wrist evaluation (0-100, lower score, means better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimal invasive', 'Osteosynthesis', 'Conservative treatment', 'Cost effectiveness'], 'conditions': ['Radius Fracture Distal']}, 'descriptionModule': {'briefSummary': 'Nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. In this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. Potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. Potential drawbacks are surgical risks and complications.', 'detailedDescription': 'Randomized controlled trial Number still to be determined by power analysis on economical outcome measurement Similar study number = 90 Randomization by computer.\n\nRZ Tienen, Dr Goorens Level 4 hand surgeon\n\nInclusion criteria:\n\n* Stable distal radial fractures (volar tilt \\<10° dorsal tilt, \\<2mm impaction, \\<2mm articular depression)\n* 18 - 65 years, professional active\n\nExclusion criteria:\n\n* associated lesions, open fractures, unstable, displaced fractures\n* neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist\n\nTreatment\n\n1. Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks\n2. Minimal invasive plating: no cast\n\nFollowup 2 weeks, 6 weeks, 3 months, 6 months, 1 year\n\nPrimary PROM:\n\n* Cost effectiveness: QALY SF-36\n* Direct costs: surgery, hospitalisation, follow-up consultations, imaging, medication, wound care, nurse cost, physiotherapy cost\n* Indirect costs: loss of productivity (SF-HLQ)\n* Health insurances costs\n* Confounding factors\n\n * Independent vs servant\n * Insurance?\n * Work type?\n * Age, sex, dominance\n* Work absence, professional recuperation\n* Recreational sport resumption\n\nSecondary PROM\n\n* ROM (F/E/RD/UD/P/S)\n* Grip strength (Jamar)\n* Pain (VAS)\n* DASH scare, PRWE score\n* Satisfaction (VAS), would you do it again?\n* RX ulna variance, radial tilt\n* complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable distal radial fractures (volar tilt \\<10° dorsal tilt, \\<2mm impaction, \\<2mm articular depression)\n* 18 - 65 years, professional active\n\nExclusion Criteria:\n\n* associated lesions, open fractures, unstable, displaced fractures\n* neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist'}, 'identificationModule': {'nctId': 'NCT05015556', 'briefTitle': 'Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'Regionaal Ziekenhuis Heilig Hart Tienen'}, 'officialTitle': 'Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.', 'orgStudyIdInfo': {'id': '109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Casting', 'description': 'Casting of the distal radius for 6 weeks'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal invasive volar plating', 'description': 'Muscle sparing osteosynthesis, no casting postoperatively', 'interventionNames': ['Procedure: Minimal invasive volar plating']}], 'interventions': [{'name': 'Minimal invasive volar plating', 'type': 'PROCEDURE', 'description': 'Muscle sparing osteosynthesis, no casting postoperatively', 'armGroupLabels': ['Minimal invasive volar plating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3300', 'city': 'Tienen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'chul ki goorens, md', 'role': 'CONTACT'}, {'name': 'chul ki goorens, md', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'niels debaenst, md', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of orthopaedics RZ Tienen', 'geoPoint': {'lat': 50.80745, 'lon': 4.9378}}], 'centralContacts': [{'name': 'chul ki goorens, MD', 'role': 'CONTACT', 'email': 'cgoorens@msn.com', 'phone': '0032478907124'}], 'overallOfficials': [{'name': 'Lieselot Brepoels, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RZ Tienen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'clinical and economical data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goorens Chul Ki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Principal Investigator', 'investigatorFullName': 'Goorens Chul Ki', 'investigatorAffiliation': 'Regionaal Ziekenhuis Heilig Hart Tienen'}}}}