Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Carpal Tunnel Syndrome Clinical Trial

Official title:

Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062722
• Other study ID #: CI.063-2014
• Status: Completed
• Phase: N/A
• First received: February 20, 2017
• Last updated: February 22, 2017
• Start date: January 1, 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: February 2017
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.

Description:

Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 1, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.

Exclusion Criteria:

• Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Charcot-Marie-Tooth Disease
• Entrapment Neuropathy
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Syndrome

Intervention

Procedure:
• keyhole approach
The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ivan Segura Duran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levine Severity Scale	pain grades with 5 grades of intensity	2 years follow up