- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02766114
Carpal Tunnel Release Through Mini Transverse Approach (CTRMTA)
May 6, 2016 updated by: Issa, Abdulhamid Sayed, M.D.
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aleppo, Syrian Arab Republic
- Dr. Sayed Issa's Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
- Participant cooperation sufficient to operate under local anesthesia
Exclusion Criteria:
- Un controlled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Patients with history of Carpal Tunnel release surgery failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Issa1
After local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist.
|
Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with post surgical trauma
Time Frame: Up to eight weeks
|
Up to eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of rehabilitation period
Time Frame: Up to three weeks
|
Up to three weeks
|
Proportion of patients with cosmetic scar
Time Frame: Up to 6 months
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 4, 2016
First Submitted That Met QC Criteria
May 6, 2016
First Posted (Estimate)
May 9, 2016
Study Record Updates
Last Update Posted (Estimate)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
- Safety
- Surgery
- Satisfaction
- Cosmetic
- Complications
- Carpal tunnel syndrome
- Rehabilitation,
- CTS
- Endoscopic Carpal Tunnel Release
- Carpal tunnel release
- Mini incision of carpal tunnel release
- Cosmetic surgery of carpal tunnel syndrome
- endoscopic carpal tunnel surgery
- Carpal Tunnel Release Through Mini Transverse Approach
- Dr. Sayed Issa's Approach
- CTRMTA
- OCTR
- ECTR
- Open Carpal Tunnel Release
- Syria
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sayed Issa's Approach
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
David TangRecruitingCarpal Tunnel Syndrome | Splints | Carpal Tunnel | Nerve Compression | Carpal Tunnel Release | Hand Injuries and DisordersCanada
-
Hospital Italiano de Buenos AiresWithdrawn
Clinical Trials on Carpal tunnel release through Mini Transverse Approach
-
Yonsei UniversityCompletedIdiopathic Carpal Tunnel SyndromeKorea, Republic of
-
Mansoura UniversityCompletedCarpal Tunnel Syndrome | IncisionEgypt
-
The Second Hospital of QinhuangdaoCompletedCarpal Tunnel SyndromeChina
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownCarpal Tunnel Syndrome | Osteoarthritis ThumbSpain
-
Combined Military Hospital AbbottabadCompletedCarpal Tunnel SyndromePakistan
-
Mayo ClinicSuspendedCarpal Tunnel SyndromeUnited States
-
Penn State UniversityCompletedCarpal Tunnel SyndromeUnited States
-
Vanderbilt UniversityTerminated
-
Gelre HospitalsDeventer ZiekenhuisRecruitingCarpal Tunnel Syndrome | Wound Infection | Suture, ComplicationNetherlands
-
Sonex Health, Inc.Terminated