Clinical trial NCT02739945: Sonographic Examination Cubital Tunnel Release
Official title: Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulnar Nerve Compression, Cubital Tunnel
Keywords: Ulnar Nerve Compression, Cubital Tunnel
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: American Shoulder and Elbow Society Function Score
timeFrame: 12 months postoperatively.
Secondary outcomes:
measure: Jamar dynamometer (grip strength)
timeFrame: 12 months postoperatively.
measure: Static-2 point discrimination test
timeFrame: 12 months postoperatively.
measure: 4-point Likert-type scale
timeFrame: 12 months postoperatively.
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Dr.Lucchina Stefano
state: Canton Ticino
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Stefano Lucchina, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.7863/jum.1999.18.6.433. No abstract available.
citation: Martinoli C, Bianchi S, Derchi LE. Ultrasonography of peripheral nerves. Semin Ultrasound CT MR. 2000 Jun;21(3):205-13. doi: 10.1016/s0887-2171(00)90043-x.
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. doi: 10.1054/jhsb.1999.0350.
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.
citation: Hoffmann R, Siemionow M. The endoscopic management of cubital tunnel syndrome. J Hand Surg Br. 2006 Feb;31(1):23-9. doi: 10.1016/j.jhsb.2005.08.008. Epub 2005 Oct 12.
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. doi: 10.1016/s1058-2746(99)90159-3.
citation: 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. doi: 10.7863/jum.1998.17.10.643.