Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-28 @ 4:58 PM
Study NCT ID:
NCT02548260
Status:
TERMINATED
Last Update Posted:
2018-08-07
First Post:
2015-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005383', 'term': 'Finger Injuries'}], 'ancestors': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in digital mobility of wounded finger', 'timeFrame': '3 weeks, 6 weeks, 3 months, 6 months', 'description': 'Evaluation of digital mobility by measuring the palm-tip of the finger distance with a ruler. The active and passive mobility of the metacarpophalangeal, proximal and distal interphalangeal joints will be measured with a goniometer.'}], 'secondaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': '3 weeks, 6 weeks, 3 months, 6 months', 'description': 'Patient has to rate the pain in the wounded finger during the last two days using a visual analog scale.'}, {'measure': 'Global function', 'timeFrame': '3 months', 'description': 'Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.'}, {'measure': 'Satisfaction', 'timeFrame': '3 months', 'description': 'Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)'}, {'measure': 'Cost', 'timeFrame': 'six months', 'description': 'The cost of the whole treatment will be calculated for each patient after the final consultation at 6 months. It will include the consultations themselves, the cost of the devices used, the hand therapy, the absence from work.'}, {'measure': 'Change in strength', 'timeFrame': '3 weeks, 6 weeks, 3 months, 6 months', 'description': 'Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)'}, {'measure': 'Change in finger diameter', 'timeFrame': '3 weeks, 6 weeks, 3 months, 6 months', 'description': 'Diameter of the injured finger at the proximal interphalangeal joint will be assessed with a specific device (rings of various diameter)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Finger Injuries']}, 'descriptionModule': {'briefSummary': 'Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. The investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.', 'detailedDescription': 'Proximal interphalangeal joint (PIPJ) injuries of the fingers are a common occurrence. They may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. Immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain.\n\nInjuries to the joints of the hand produce edema that is responsible for additional stiffness. Compressive garment may be worn to limit the extent of the edema and help its resorption.\n\nAlthough PIPJ injuries are frequent, their treatment does not benefit from a consensus. Most studies are retrospective or aimed at a pediatric population. The investigators wish to evaluate the outcome of PIPJ injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.The investigators also wish to study the effect of finger compression on edema resolution and finger motion. Therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression.\n\nThe study will be conducted in the hand surgery unit of a university hospital in a prospective way. The assignment to a particular treatment group will be randomly performed. Patients will be followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proximal interphalangeal joint injury with or without dorsal or lateral luxation\n* less than seven days after injury\n* injured joint stability\n* fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface\n\nExclusion Criteria:\n\n* palmar luxation of the proximal interphalangeal joint\n* fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface\n* injury to the central band of the extensor tendon\n* fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface\n* non reducible luxation'}, 'identificationModule': {'nctId': 'NCT02548260', 'briefTitle': 'Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression', 'orgStudyIdInfo': {'id': '301/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Syndactyly without compression', 'description': 'Relative immobilization with a syndactyly (CE conformity), no compression is worn.', 'interventionNames': ['Device: Syndactyly without compression']}, {'type': 'EXPERIMENTAL', 'label': 'Syndactyly with compression', 'description': 'Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger', 'interventionNames': ['Device: Syndactyly with compression']}, {'type': 'EXPERIMENTAL', 'label': 'Rigid splint without compression', 'description': 'Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn', 'interventionNames': ['Device: Rigid splint without compression']}, {'type': 'EXPERIMENTAL', 'label': 'Rigid splint with compression', 'description': 'Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger', 'interventionNames': ['Device: Rigid splint with compression']}], 'interventions': [{'name': 'Syndactyly without compression', 'type': 'DEVICE', 'description': 'three week relative immobilization by syndactyly', 'armGroupLabels': ['Syndactyly without compression']}, {'name': 'Syndactyly with compression', 'type': 'DEVICE', 'description': 'three week relative immobilization by syndactyly and compression', 'armGroupLabels': ['Syndactyly with compression']}, {'name': 'Rigid splint without compression', 'type': 'DEVICE', 'description': 'three week rigid immobilization by splint', 'armGroupLabels': ['Rigid splint without compression']}, {'name': 'Rigid splint with compression', 'type': 'DEVICE', 'description': 'three week rigid immobilization by splint and compression', 'armGroupLabels': ['Rigid splint with compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1005', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff physician', 'investigatorFullName': 'Thierry Christen', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}