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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02739945
Other study ID # EnteOC
Secondary ID
Status Completed
Phase Phase 3
First received April 10, 2016
Last updated April 14, 2016
Start date May 2011
Est. completion date April 2016

Study information

Verified date April 2016
Source Ente Ospedaliero Cantonale, Bellinzona
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 85 Years
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Procedure:
Cubital tunnel release
The ulnar nerve is decompressed proximally at the intramuscular septum, decompressed more distally through the cubital tunnel and then exposed between the two heads of the flexor carpi ulnaris muscle. Care is taken to ensure that any point that might compress the ulnar nerve either proximally or distally is evaluated.

Locations

Country Name City State
Switzerland Dr.Lucchina Stefano Locarno Canton Ticino

Sponsors (1)

Lead Sponsor Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

Chiou HJ, Chou YH, Cheng SP, Hsu CC, Chan RC, Tiu CM, Teng MM, Chang CY. Cubital tunnel syndrome: diagnosis by high-resolution ultrasonography. J Ultrasound Med. 1998 Oct;17(10):643-8. — View Citation

Hoffmann R, Siemionow M. The endoscopic management of cubital tunnel syndrome. J Hand Surg Br. 2006 Feb;31(1):23-9. Epub 2005 Oct 12. — View Citation

King GJ, Richards RR, Zuckerman JD, Blasier R, Dillman C, Friedman RJ, Gartsman GM, Iannotti JP, Murnahan JP, Mow VC, Woo SL. A standardized method for assessment of elbow function. Research Committee, American Shoulder and Elbow Surgeons. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):351-4. — View Citation

Martinoli C, Bianchi S, Derchi LE. Ultrasonography of peripheral nerves. Semin Ultrasound CT MR. 2000 Jun;21(3):205-13. — View Citation

Okamoto M, Abe M, Shirai H, Ueda N. Diagnostic ultrasonography of the ulnar nerve in cubital tunnel syndrome. J Hand Surg Br. 2000 Oct;25(5):499-502. — View Citation

Puig S, Turkof E, Sedivy R, Ciovica R, Lang S, Kainberger FM. Sonographic diagnosis of recurrent ulnar nerve compression by ganglion cysts. J Ultrasound Med. 1999 Jun;18(6):433-6. — View Citation

Watts AC, Bain GI. Patient-rated outcome of ulnar nerve decompression: a comparison of endoscopic and open in situ decompression. J Hand Surg Am. 2009 Oct;34(8):1492-8. doi: 10.1016/j.jhsa.2009.05.014. Epub 2009 Aug 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary American Shoulder and Elbow Society Function Score Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale 12 months postoperatively. No
Secondary Jamar dynamometer (grip strength) 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 12 months postoperatively. No
Secondary Static-2 point discrimination test 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.
12 months postoperatively. No
Secondary 4-point Likert-type scale 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) 12 months postoperatively. No