Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT01562860
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2011-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2012-03-22', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)", 'timeFrame': '12 months', 'description': 'The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['median nerve', 'carpal tunnel syndrome', 'Pronator Teres Release'], 'conditions': ['Median Nerve Compression']}, 'descriptionModule': {'briefSummary': 'The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres\n* Normal two point discrimination\n* Over the age of 18 and under the age of 65\n\nExclusion Criteria:\n\n* Peripheral neuropathy of the median nerve secondary to trauma\n* Presence of thoracic outlet syndrome\n* Presence of cervical disk disease\n* Under the age of 18 and over the age of 65'}, 'identificationModule': {'nctId': 'NCT01562860', 'briefTitle': 'Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Christine M. Kleinert Institute for Hand and Microsurgery'}, 'officialTitle': 'The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': '10.0039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carpal Tunnel and Pronator Teres Release', 'description': 'Patients enrolled in this arm of the study will have both surgical procedures performed at the same time', 'interventionNames': ['Procedure: dual compression release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carpal Tunnel Release only', 'description': 'Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.', 'interventionNames': ['Procedure: Pronator Teres Release', 'Procedure: dual compression release', 'Procedure: median nerve release only']}], 'interventions': [{'name': 'Pronator Teres Release', 'type': 'PROCEDURE', 'otherNames': ['carpal tunnel release'], 'description': 'Surgical release of median nerve compression', 'armGroupLabels': ['Carpal Tunnel Release only']}, {'name': 'dual compression release', 'type': 'PROCEDURE', 'description': 'Both the carpal tunnel compression and the pronator teres compression will be released on the same day.', 'armGroupLabels': ['Carpal Tunnel Release only']}, {'name': 'dual compression release', 'type': 'PROCEDURE', 'description': 'both procedures will be done on the same day', 'armGroupLabels': ['Carpal Tunnel and Pronator Teres Release']}, {'name': 'median nerve release only', 'type': 'PROCEDURE', 'description': 'only the carpal tunnel compression is released', 'armGroupLabels': ['Carpal Tunnel Release only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina L Kaufman, PhD', 'role': 'CONTACT', 'email': 'ckaufman@cmki.org', 'phone': '502-562-0390'}, {'name': 'Millicent L Horn, BS', 'role': 'CONTACT', 'email': 'mhorn@cmki.org', 'phone': '502-562-0307'}, {'name': 'Tuna Ozyurekoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christine M. Kleinert Institute for Hand and Microsurgery', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Tuna Ozyurekoglu, MD', 'role': 'CONTACT', 'email': 'tozyurekoglu@cmki.org', 'phone': '502-561-4263'}, {'name': 'Millicent L Horn, BS', 'role': 'CONTACT', 'email': 'mhorn@cmki.org', 'phone': '502-562-0307'}], 'overallOfficials': [{'name': 'Tuna Ozyurekoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christine M. Kleinert Institute for Hand and Microsurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christine M. Kleinert Institute for Hand and Microsurgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}