Sonographic Examination Cubital Tunnel Release

Phase 3

Completed

• Conditions: Ulnar Nerve Compression, Cubital Tunnel

• Registration Number: NCT02739945
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief Summary

The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.

Detailed Description

The investigators want to compare changes in CSA of the ulnar nerve at the elbow hypothesizing that US examination is a useful tool to detect unsuccessful release and defining which technique shows the best outcome in the first year postoperatively.

The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described. US typically demonstrates an abrupt narrowing and displacement of the nerve within the tunnel, possibly in association with a thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2016-01
• Status Verified: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-04-10
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• history of paresthesia or numbness in the ulnar nerve distribution;
• weakness or wasting of the small muscles of the hand;
• a positive elbow flexion provocation test;
• slowed motor conduction velocity in the ulnar nerve below 50 m/sec.

Exclusion Criteria

• Patients with normal nerve conduction studies;
• prior surgery for Cubital Tunnel Syndrome;
• prior traumatic lesions of the elbow;
• coexistent neurological diseases;
• bone anormalities (cubitus valgus, deformities from previous elbow fractures, osteoarthritis with medial osteophytes ands loose bodies, heterotopic ossifications);
• subluxating ulnar nerve;
• space-occupying soft-tissue lesions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Society Function Score	12 months postoperatively.	Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale

Secondary Outcome Measures

Name	Time	Method
Static-2 point discrimination test	12 months postoperatively.	Two-point discrimination is the ability to discern that two nearby objects touching the skin are truly two distinct points.; Two-point discrimination has long been used as an assessment tool for tactile gnosis, and to assess recovery after a peripheral nerve surgery.
4-point Likert-type scale	12 months postoperatively.	Patients undergoing surgical decompression indicate their postoperative clinical outcome on a questionnaire using 4-point Likert-type scale (1= large improvement, 2 = moderate improvement, 3= no improvement, 4= worse than preoperatively)
Jamar dynamometer (grip strength)	12 months postoperatively.	Quantitative measurement of grip strength were assessed with a Jamar dynamometer. The Jamar Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. The Jamar dynamometer was introduced in 1954 (Bechtol,1954). It consists of a sealed hydraulic system with adjustable hand spacings that measures handgrip force

Trial Locations

Locations (1)

Dr.Lucchina Stefano; 🇨🇭 Locarno, Canton Ticino, Switzerland