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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02726165
Other study ID # ASI001
Secondary ID
Status Completed
Phase N/A
First received March 21, 2016
Last updated April 3, 2016
Start date February 2013
Est. completion date March 2016

Study information

Verified date March 2016
Source Issa, Abdulhamid Sayed, M.D.
Contact n/a
Is FDA regulated No
Health authority Syrian Arab Republic: Ethics Committee
Study type Interventional

Clinical Trial Summary

Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.


Description:

Carpal tunnel release through small approach on the the distal wrist crease, it is about one and half centimetres, 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 70 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Carpal tunnel release through Mini Transverse Approach
Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Issa, Abdulhamid Sayed, M.D.

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with post surgical trauma Up to eight weeks Yes
Secondary Duration of rehabilitation period Up to three weeks Yes
Secondary Proposition of patients with cosmetic scar Up to 6 months Yes
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