SPECTRE
Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
April 2016
Actual (reported)The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)April 2016
Actual (reported)April 10, 2016
Actual (reported)April 15, 2016
Actual (reported)American Shoulder and Elbow Society Function Score
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
12 months postoperatively.
Jamar dynamometer (grip strength)
12 months postoperatively.
Static-2 point discrimination test
12 months postoperatively.
4-point Likert-type scale
12 months postoperatively.
In situ decompression (MacKinnon and Novak 2005) is made through a 6-10 cm longitudinal incision along the course of the ulnar nerve midway between the medial epicondyle and the olecranon.
Endoscopic release follows Hoffmann's technique (Hoffmann 2006) that demonstrated the safety and efficacy of this technique in a cadaveric model and in a clinical study.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dr.Lucchina Stefano
Locarno, Canton Ticino, 6600, Switzerland
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.
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.
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.
Stefano Lucchina, MD
Ente Ospedaliero Cantonale, Bellinzona
60 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2016
First Posted
April 15, 2016
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
January 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
April 15, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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