Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

NCT03062722 | Completed DMC

• 1 other identifier: CI.063-2014
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carpal Tunnel Syndrome; Entrapment Neuropathy

Keywords

microsurgical treatment; pain; dexterity; Phalen sign; functional status

Outcome Measures

Primary Outcomes (1)

• Levine Severity Scale

  pain grades with 5 grades of intensity

  2 years follow up

Study Arms (1)

keyhole approach

EXPERIMENTAL

open minimally invasive approach

Procedure: keyhole approach

Interventions

keyhole approach PROCEDURE

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.

keyhole approach

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ivan Segura Duran: lead

Related Publications (1)

• Ramos-Zuniga R, Garcia-Mercado CJ, Segura-Duran I, Zepeda-Gutierrez LA. Efficacy of Keyhole Approach to Carpal Tunnel Syndrome under Ambulatory Strategy. Neurol Res Int. 2017;2017:3549291. doi: 10.1155/2017/3549291. Epub 2017 Apr 6.

  PMID: 28484650 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Charcot-Marie-Tooth Disease; Pain

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo Ramos Zuñiga, M.D. PhD

  Universidad se Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share