Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-02 @ 12:01 AM
Study NCT ID:
NCT01756820
Status:
WITHDRAWN
Last Update Posted:
2016-05-11
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The principal investigator of the study relocated to another institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2012-12-26', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Satisfaction', 'timeFrame': 'at 1 and 6 months postoperatively', 'description': 'Satisfaction will be assessed by two ways\n\n* by answering to the question "are you happy with the result of the surgery?"\n* with a VAS score (0-100) assessing the satisfaction'}, {'measure': 'Complications', 'timeFrame': 'up to 6 months postoperatively', 'description': 'Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'at 1 and 6 months postoperatively', 'description': 'Pain will be assessed\n\n* as a dichotomous outcome (yes/no)\n* as a continuous outcome (VAS score)'}, {'measure': 'Grip strength', 'timeFrame': 'at 1 and 6 months postoperatively'}, {'measure': 'key pinch', 'timeFrame': 'at 1 and 6 months postoperatively'}, {'measure': 'Time to return to Activities of Daily Living (ADL) and return to work', 'timeFrame': 'up to the end of the study', 'description': 'Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.'}, {'measure': 'Recurrences and reoperations', 'timeFrame': 'up to the end of study'}, {'measure': 'Symptom Severity Scale (SSS)', 'timeFrame': 'at 1 and 6 months postoperatively'}, {'measure': 'Function Severity Status (FSS)', 'timeFrame': 'at 1 and 6 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'transverse ligament', 'carpal tunnel release', 'endoscopic', 'minimal invasive', 'mini-open', 'median nerve'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary Carpal Tunnel Syndrome\n* no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)\n\n * electrophysiological examination confirms the Carpal Tunnel Syndrome\n\nExclusion Criteria:\n\n* Secondary Carpal Tunnel Syndrome\n* Pregnancy\n* Rheumatoid diseases\n* Previous trauma at hand or other condition that may effect the anatomy (eg infections)"}, 'identificationModule': {'nctId': 'NCT01756820', 'acronym': 'CTS-HV', 'briefTitle': 'Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Ioannina'}, 'officialTitle': 'Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'Ioannina-CTS-HV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single-portal Endoscopic Carpal Tunnel Release (Microaire®)', 'description': 'Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.', 'interventionNames': ['Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Knifelight®', 'description': 'A mini-open technique will be performed, using the Knifelight® (Stryker).', 'interventionNames': ['Procedure: Knifelight']}], 'interventions': [{'name': 'Single-portal Endoscopic Carpal Tunnel Release (Microaire®)', 'type': 'PROCEDURE', 'otherNames': ['SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.'], 'description': 'SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).', 'armGroupLabels': ['Single-portal Endoscopic Carpal Tunnel Release (Microaire®)']}, {'name': 'Knifelight', 'type': 'PROCEDURE', 'otherNames': ['Knifelight®, Stryker'], 'description': 'A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)', 'armGroupLabels': ['Knifelight®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45500', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}], 'overallOfficials': [{'name': 'Haris S Vasiliadis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics, School of Medicine, University of Ioannina, Greece'}, {'name': 'Theodoros Xenakis', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Orthopaedics, School of Medicine, University of Ioannina, Greece'}, {'name': 'Grigorios Mitsionis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Orthopaedics, School of Medicine, University of Ioannina, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Orthopaedics', 'investigatorFullName': 'Haris S Vasiliadis, MD, PhD', 'investigatorAffiliation': 'University of Ioannina'}}}}