Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-18 @ 6:31 AM
Study NCT ID:
NCT04403958
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion rate (percent)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pain (Visual Analogue Scale)', 'timeFrame': '6 months', 'description': 'The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)'}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE)', 'timeFrame': '6 months', 'description': 'The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)'}, {'measure': 'Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)', 'timeFrame': '6 months', 'description': 'The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)'}, {'measure': 'Global improvement', 'timeFrame': '6 months', 'description': 'Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better'}, {'measure': 'Grip strength', 'timeFrame': '6 months', 'description': 'Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side'}, {'measure': 'Operative time', 'timeFrame': 'Perioperative', 'description': 'Operative time is measured in minutes for time in the operation theatre and time used for surgery'}, {'measure': 'Complications', 'timeFrame': '12 months', 'description': 'Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrist Arthritis', 'Fusion; Joint']}, 'descriptionModule': {'briefSummary': 'Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft.\n\nPatients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.\n\nBaseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 75\n* Symptom duration \\> 3 months\n* American Society of Anaesthesiologists physical status (ASA) I-III\n* Fluent in written and spoken Finnish\n\nExclusion Criteria:\n\n* Age \\<18 or \\>75 years\n* Rheumatoid arthritis\n* Heavy smoking (\\> 20 cigarettes per day)\n* Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)\n* Ulnar variance \\> 1 mm\n* Wrist pain treatable with partial wrist fusion\n* Previous partial wrist fusion\n* Alcohol or drug abuse\n* Neurological condition affecting upper limb function\n* Less than 6 months after another operation of the same upper limb'}, 'identificationModule': {'nctId': 'NCT04403958', 'acronym': 'PROOF II', 'briefTitle': 'The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Töölö Hospital'}, 'officialTitle': 'The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)', 'orgStudyIdInfo': {'id': '1467/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRC', 'description': 'Total wrist arthrodesis with PRC and dorsal plate', 'interventionNames': ['Procedure: PRC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TWA', 'description': 'Total wrist arthrodesis with dorsal plate', 'interventionNames': ['Procedure: TWA']}], 'interventions': [{'name': 'PRC', 'type': 'PROCEDURE', 'description': 'Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft', 'armGroupLabels': ['PRC']}, {'name': 'TWA', 'type': 'PROCEDURE', 'description': 'Total wrist arthrodesis with dorsal plate using iliac crest as bone graft', 'armGroupLabels': ['TWA']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samuli Aspinen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'samuli.aspinen@hus.fi', 'phone': '+358406360546'}, {'name': 'Jorma Ryhänen, adj. prof.', 'role': 'CONTACT', 'email': 'jorma.ryhanen@hus.fi'}], 'overallOfficials': [{'name': 'Samuli Aspinen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUS Töölö Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Töölö Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Kymenlaakso Central Hospital Kotka Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Samuli Aspinen', 'investigatorAffiliation': 'Töölö Hospital'}}}}