Sonographic Examination Cubital Tunnel Release

Ulnar Nerve Compression, Cubital Tunnel Clinical Trial

— SPECTRE  

Official title:

Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739945
• Other study ID #: EnteOC
• 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

• Cubital Tunnel Syndrome
• Ulnar Nerve Compression, Cubital Tunnel

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