Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05127005
Status:
RECRUITING
Last Update Posted:
2022-01-21
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported wrist and hand evaluation (PRWHE)', 'timeFrame': '6 months', 'description': 'PROM questionnaire'}], 'secondaryOutcomes': [{'measure': 'Patient reported wrist and hand evaluation (PRWHE)', 'timeFrame': '3 months, and 1, 2, 5 years', 'description': 'PROM questionnaire'}, {'measure': 'Global improvement', 'timeFrame': '3 and 6 months, and 1, 2, and 5 years', 'description': 'PROM, question (Likert scale)'}, {'measure': 'Patient accepted symptom state', 'timeFrame': '3 and 6 months, and 1, 2, and 5 years', 'description': 'PROM, question (Likert scale)'}, {'measure': 'Grip and pinch strength', 'timeFrame': '6 months', 'description': 'Measured with dynamometer'}, {'measure': 'EUROQOL EQ-5D-5L', 'timeFrame': '3 and 6 months, and 1, 2, and 5 years', 'description': 'PROM, health-related quality of life questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thumb Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.', 'detailedDescription': 'A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living\n2. Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.\n3. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)\n4. Age \\> 45 years\n5. ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)\n6. Ability to speak, understand and read in the language of the clinical site\n7. Provision of informed consent from the participant\n\nExclusion Criteria:\n\n1. Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy\n2. Neurologic condition affecting the function or symptoms of the upper extremity\n3. \\<6 months from other surgical procedure of the upper extremities\n4. Rheumatoid arthritis or other inflammatory joint disease\n5. Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides\n6. Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side\n7. \\>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)\n8. Patient is unable to continue his/her current job due to thumb pain"}, 'identificationModule': {'nctId': 'NCT05127005', 'acronym': 'FINTASY', 'briefTitle': 'Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb', 'orgStudyIdInfo': {'id': 'TAUH_FINTASY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trapeziectomy', 'description': 'Trapeziectomy', 'interventionNames': ['Procedure: Trapeziectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham surgery', 'description': 'Sham surgery', 'interventionNames': ['Procedure: Sham']}, {'type': 'OTHER', 'label': 'Non-randomized observational arm', 'description': 'Non-randomized observational arm (trapeziectomy, not blinded)', 'interventionNames': ['Procedure: Trapeziectomy']}], 'interventions': [{'name': 'Trapeziectomy', 'type': 'PROCEDURE', 'description': 'Surgical excision of trapezoideum', 'armGroupLabels': ['Non-randomized observational arm', 'Trapeziectomy']}, {'name': 'Sham', 'type': 'PROCEDURE', 'description': 'Skin incision only', 'armGroupLabels': ['Sham surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Eero Waris', 'role': 'CONTACT'}], 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Jyväskylä', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Teemu Karjalainen', 'role': 'CONTACT'}], 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Yrjänä Nietosvaara', 'role': 'CONTACT'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jarkko Jokihaara', 'role': 'CONTACT'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Jarkko Jokihaara', 'role': 'CONTACT', 'email': 'jarkko.jokihaara@pshp.fi', 'phone': '+3583311611'}], 'overallOfficials': [{'name': 'Jarkko Jokihaara', 'role': 'STUDY_CHAIR', 'affiliation': 'TAUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In this trial IPD sharing is restricted by data protection regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Central Finland Central Hospital', 'class': 'UNKNOWN'}, {'name': 'University of Eastern Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jarkko Jokihaara', 'investigatorAffiliation': 'Tampere University Hospital'}}}}