Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT00880295
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2009-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2009-04-10', 'studyFirstSubmitQcDate': '2009-04-10', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome: patient satisfaction via surveys used in prior publications', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': "Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria:\n\n1. Primary outcome: patient satisfaction via surveys used in prior publications\n2. Secondary outcome: length of time to return to work\n3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's\n4. Secondary outcome: complication rates"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between the ages of 18 and 75\n2. Documented clinical and electromyography (EMG) proven carpal tunnel syndrome\n\nExclusion Criteria:\n\n1. Recurrent carpal tunnel syndrome\n2. Inflammatory arthropathy\n3. Peripheral neuropathy\n4. Diabetes\n5. \\< 18 or \\> 75 years old\n6. Pregnant at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT00880295', 'briefTitle': 'Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications', 'orgStudyIdInfo': {'id': '24457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'endoscopic surgery', 'interventionNames': ['Procedure: endoscopic carpal tunnel release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'open surgery', 'interventionNames': ['Procedure: open carpal tunnel release']}], 'interventions': [{'name': 'endoscopic carpal tunnel release', 'type': 'PROCEDURE', 'description': 'endoscopic surgery, which is standard of care for carpal tunnel release', 'armGroupLabels': ['endoscopic surgery']}, {'name': 'open carpal tunnel release', 'type': 'PROCEDURE', 'description': 'open surgery, which is standard of care for carpal tunnel release', 'armGroupLabels': ['open surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Stephen Nogan, B.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}