Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-23 @ 12:03 AM
Study NCT ID:
NCT02015468
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2013-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)', 'timeFrame': '2 years', 'description': 'The Quick-DASH score is a measure of patient reported satisfaction score and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone.'}, {'measure': 'Short Form 36 (SF36)', 'timeFrame': '2 years', 'description': 'The SF-36 score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}], 'secondaryOutcomes': [{'measure': 'Patient Rated Wrist Evaluation (PRWE)', 'timeFrame': '2 years', 'description': 'The PRWE-score is a measure of patient reported satisfaction and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}, {'measure': 'Euro-Qol 5 dimension score (EQ-5d)', 'timeFrame': '2 years', 'description': 'The EQ-5d score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}, {'measure': 'Pain Scores on the Visual Analog Scale (VAS)', 'timeFrame': '2 years', 'description': 'The VAS-score is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}, {'measure': 'Radiological findings (X-ray)', 'timeFrame': '2 years', 'description': 'Angles, incongruity and other radiological parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}, {'measure': 'Range of motion (ROM)', 'timeFrame': '2 yars', 'description': 'Wrist range of motion is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}, {'measure': 'Cost analysis', 'timeFrame': '2 years', 'description': 'The cost of treatment, sick-leave, complications and other socioeconomical parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Distal radius fracture', 'Wrist fracture', 'Physiotherapy', 'Immobilization', 'Volar locking plates', 'Mobilization'], 'conditions': ['Distal Radius Fracture', 'Wrist Fracture']}, 'descriptionModule': {'briefSummary': 'A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.\n\nThe current study will test the following null hypothesis:\n\nThere is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.', 'detailedDescription': 'The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.\n\nIn a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPosition prior to primary reduction:\n\n* Dorsal tilt \\> 25°\n* Radial shortening\\> 6 mm\n* Radial inclination reduced by more than 15°\n* Radiocarpal malalignment \\> 7 mm\n* Dorsal /volar metaphyseal comminution\n* Volar displacement of the distal fragment(= Smith's fracture)\n\nPosition after initial reduction:\n\n* Dorsal tilt \\> 5°\n* Radial shortening \\> 4 mm\n* Radial inclination reduced by more than 10°\n* Radiocarpal malalignment \\> 4 mm\n\nExclusion Criteria:\n\n1. Gustilo-Anderson type III open fractures\n2. Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity\n3. Previous distal radius fracture or other disabling injury to the contralateral side\n4. Dementia or other psychiatric illness which affect compliance\n5. Congenital anomaly\n6. Bilateral radius fracture\n7. Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities\n8. Systemic joint disease such as rheumatoid arthritis\n9. Patients who do not speak Norwegian\n10. Pathological fracture other than osteoporotic fracture\n11. Congenital bone disease (for example osteogenesis imperfecta)\n12. Age below 18 and above 70\n13. Patients not belonging to Akershus University Hospital"}, 'identificationModule': {'nctId': 'NCT02015468', 'briefTitle': 'The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating', 'orgStudyIdInfo': {'id': '2011/1393A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early mobilization', 'interventionNames': ['Other: Early mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Late mobilization', 'interventionNames': ['Other: Late mobilization']}], 'interventions': [{'name': 'Early mobilization', 'type': 'OTHER', 'description': 'Early weightbearing and physiotherapy', 'armGroupLabels': ['Early mobilization']}, {'name': 'Late mobilization', 'type': 'OTHER', 'description': 'Late mobilization, none-weightbearing and home exercises', 'armGroupLabels': ['Late mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Oslo', 'state': 'Lorenskog', 'country': 'Norway', 'facility': 'Akershus University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jan Erik Madsen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD-student', 'investigatorFullName': 'Ola-Lars Hammer', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}