Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Not Applicable

Completed

• Conditions: Entrapment Neuropathy; Carpal Tunnel Syndrome
• Interventions: Procedure: keyhole approach

• Registration Number: NCT03062722
• Lead Sponsor: Ivan Segura Duran

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.

Detailed 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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-12-01
• Study Completion: 2016-07-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
keyhole approach	keyhole approach	open minimally invasive approach

Primary Outcome Measures

Name	Time	Method
Levine Severity Scale	2 years follow up	pain grades with 5 grades of intensity