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Clinical Trial 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.


Clinical Trial Description

The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described (Ziswiler HR, 2002, Chiou 1998, Jacob 2004). 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 (Puig 1999, Martinoli 2000, Okamoto 2000). As assessed by quantitative analysis with US, the nerve CSA at the epicondyle is significantly larger in patients with CTS than in healthy subjects or in the opposite normal elbow. An ulnar nerve area > 7.5 mm2 (Chiou 1998) or 7.9 mm2 (Jacob 2004) at the level of the epicondyle had been indicated as the threshold value for CTS. Previous studies (Voegelin 2010, Abicalaf 2007, Colak 2007, Lee 2005) prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02739945
Study type Interventional
Source Ente Ospedaliero Cantonale, Bellinzona
Contact
Status Completed
Phase Phase 3
Start date May 2011
Completion date April 2016