Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT04675892
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2020-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}], 'ancestors': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants were randomized in two groups according to a computer-generated list ranging from 01 to 60 (www.randomization.com). Surgery was then performed according to the method chosen by randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total active finger motion in degrees', 'timeFrame': 'Preoperative (days to weeks prior to surgery), 4 weeks after surgery', 'description': 'Change in preoperative and postoperative overall range of motion of the finger joints in degrees'}], 'secondaryOutcomes': [{'measure': 'Change in with the visual analog scale', 'timeFrame': 'Preoperative (days to weeks prior to surgery), 4 weeks after surgery', 'description': 'Change in pain with the visual analog scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trigger finger', 'stenosing flexor tenosynovitis'], 'conditions': ['Trigger Finger', 'Stenosing Tenosynovitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of resection of one or both slips of the flexor digitorum superficialis tendon versus the A1 pulley division.', 'detailedDescription': 'The preoperative visit occurred a number of weeks or months prior to surgery. Surgeons from the Centre de la main at the CHUV in Lausanne recruited the subjects during their consultations. During this initial visit, the patient was asked about his problem, his general health and a clinical examination (including range of motion of finger joints, pulp-to-palm distance, pain evaluated with a VAS) was performed. Once the diagnosis of trigger finger was established, the inclusion and exclusion criteria were evaluated. If the eligibility criteria were fulfilled, the patients were offered to be part of the study. They received oral and written information about the study and the surgeons gave further explanation if needed.\n\nOn the surgery day, the signed consent form was recovered. Participants were randomized in two groups according to a computer-generated list ranging from 01 to 60 (www.randomization.com). Surgery was then performed according to the method chosen by randomization. The possible occurrence of adverse effects during surgery was monitored. All information was recorded on the case report forms.\n\nThe first postoperative visit occurred 1 week ± 3 days after surgery. The surgeons evaluated the wound to exclude the presence of postoperative complication (infection, hematoma, nerve or tendon injury) and answer any question the patient could have. Range of motion and pain were recorded. All information was recorded on the case report forms.\n\nThe second postoperative visit occurred 4 weeks ± 5 days after surgery. The appointment was conducted in the same way as the previous one.\n\nPatients could choose to be withdrawn from the study at any point. The follow-up was similar to that of patients included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years old) with a flexor tendon tenosynovitis of a finger resulting in a decreased range of motion of the PIP joint (defined with a palm-to-pulp distance ≥0mm and/or flexion contracture ≥15°).\n\nExclusion Criteria:\n\n* Minors (\\<18 years old).\n* PIP joint contracture resulting from another illness than stenosing flexor tenosynovitis (for example: rheumatoid arthritis) or caused by a traumatic event.\n* Contraindications to any surgery: presence of a severe coagulation disorder, immunosuppression or decompensated psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT04675892', 'briefTitle': 'Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Resection of One or Both Slips of the Flexor Digitorum Superficialis Tendon for Cases of Severe Trigger Fingers. a Randomized Prospective Single Center Study', 'orgStudyIdInfo': {'id': '2018-01270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A1 pulley group', 'description': 'A1 pulley division only', 'interventionNames': ['Procedure: A1 pulley division']}, {'type': 'EXPERIMENTAL', 'label': 'A1 pulley + FDS group', 'description': 'Combination of A1 pulley division and excision of one or both slips of the flexor digitorum superficialis tendon', 'interventionNames': ['Procedure: A1 pulley division + Resection of one or both slips of the FDS tendon']}], 'interventions': [{'name': 'A1 pulley division', 'type': 'PROCEDURE', 'description': 'Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %).\n\nDivision of the A1 pulley.\n\nWound closure with absorbable sutures and application of a light dressing.', 'armGroupLabels': ['A1 pulley group']}, {'name': 'A1 pulley division + Resection of one or both slips of the FDS tendon', 'type': 'PROCEDURE', 'description': 'Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %).\n\nDivision of the A1 pulley.\n\nPalmar Bruner incision over the PIP joint. Distal dissection and resection of one or both slips of the FDS tendon.\n\nWound closure with absorbable sutures and application of a light dressing.', 'armGroupLabels': ['A1 pulley + FDS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thierry Christen, MD', 'role': 'CONTACT', 'email': 'thierry.christen@chuv.ch', 'phone': '+41(0)795561287'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Thierry Christen, MD', 'role': 'CONTACT', 'email': 'thierry.christen@chuv.ch', 'phone': '+41(0)795561287'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Thierry Christen', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}