Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-18 @ 9:19 AM
Study NCT ID:
NCT05325567
Status:
TERMINATED
Last Update Posted:
2023-08-18
First Post:
2022-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Two Incision vs. Mini 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': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "Patients will be scheduled and added to the operative list of the day by the PI's primary nurse. The primary nurse is not a part of the study and will not be present in the operating room. On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'study was not renewed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '2 week post operative pain', 'timeFrame': 'two weeks', 'description': 'Reported level of pain on 0-10 pain scale, with 0 as no pain'}], 'primaryOutcomes': [{'measure': 'Resolution of carpal tunnel symptoms', 'timeFrame': 'Six weeks', 'description': 'Reporting 2 or less on the 0-10 pain scale, with 0 as no pain'}], 'secondaryOutcomes': [{'measure': 'Time to return to work', 'timeFrame': 'Six weeks', 'description': 'How long it takes the subject to return to work'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.\n\nThis study aims to determine whether sparing these superficial structures indeed improves patient outcomes, compared to a conventional two incision approach.', 'detailedDescription': 'Carpal tunnel release (CTR) is a common surgery done by hand surgeons. The aim of the procedure is to decompress the median nerve at the level of the wrist and alleviate patient symptoms that include numbness, pain and tingling sensations along the median nerve distribution. Many versions of the technique have been described, with each description claiming improvement of post-operative results and decreasing complications.\n\nThe first description of carpal tunnel release is believed to be that of Learmonth in 1933 where he describes incising the transverse carpal ligament in a lady with a wrist fracture1. Since then, the understanding towards carpal tunnel syndrome has markedly improved, and various surgical techniques have been developed.\n\nBecause carpal tunnel syndrome has become such a common condition among the population, much knowledge has been gained about carpal tunnel surgery as well. One of the easily avoided complications of the procedure is scar related morbidity and pillar pain. Bromley offered a mini-palm open carpal tunnel release technique that decompressed the median nerve while keeping the entirety of the incision distal to the wrist crease. Tsai et al and Wilson also offered two-incision open carpal tunnel release techniques in order to keep incisions small but ensure complete release both proximally and distally. Endoscopic techniques were also eventually developed with the aim of a complete release while avoiding scar related complications.\n\nWith the many options surgeons have on how to decompress the median nerve, some begin to question if techniques are being made unnecessarily complicated. Some believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.\n\nThis study aims to determine whether sparing these superficial structures indeed improves patient outcomes.\n\nHypothesis:\n\nNull hypothesis: There is no difference in post-operative outcomes between a mini-open carpal tunnel release and a two incision carpal tunnel release\n\nAlternative hypothesis: A two-incision carpal tunnel release will yield improvement in post operative outcomes compared to that of the mini-open carpal tunnel release\n\nAim of the Study:\n\nThis study aims to determine whether sparing of the soft tissue structures superficial to the transverse carpal ligament will improve post-operative outcomes of patients undergoing carpal tunnel surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants over the age of 18\n* Patients who have not undergone any prior wrist surgery that may alter the native wrist anatomy\n* Participants surgery must only be carpal tunnel release (no trigger fingers, de quervain release, etc.)\n* Participants must have read and understood the consent form for the performance of the procedure and enrollment into the study. Consent must be signed in front of the principal investigator and a witness\n\nExclusion Criteria:\n\n* Patients who are under the age of 18\n* Patients who had other major surgery on the extremity being assessed potentially altering the native anatomy of the volar wrist area\n* Patients who plan to have multiple hand procedures done along with their carpal tunnel release\n* Patients refusing to sign the consent and enrollment form for the study'}, 'identificationModule': {'nctId': 'NCT05325567', 'briefTitle': 'Comparative Study of Two Incision vs. Mini Open Carpal Tunnel Release', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release', 'orgStudyIdInfo': {'id': '21.0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 incision technique', 'description': 'a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease.', 'interventionNames': ['Procedure: Mini open incision CTR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two incision technique', 'description': 'A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally', 'interventionNames': ['Procedure: Mini open incision CTR']}], 'interventions': [{'name': 'Mini open incision CTR', 'type': 'PROCEDURE', 'otherNames': ['Two incision CTR'], 'description': 'two techniques commonly used for carpal tunnel release are being compared to determine if one vs. the other provides superior patient outcomes.', 'armGroupLabels': ['1 incision technique', 'Two incision technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kleinert Kutz Hand Care Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Huey Tien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Christine M. Kleinert Institute for Hand and Microsurgery', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}