Sonographic Examination Cubital Tunnel Release
SPECTRE
Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedApril 15, 2016
April 1, 2016
4.7 years
April 10, 2016
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American Shoulder and Elbow Society Function Score
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
12 months postoperatively.
Secondary Outcomes (3)
Jamar dynamometer (grip strength)
12 months postoperatively.
Static-2 point discrimination test
12 months postoperatively.
4-point Likert-type scale
12 months postoperatively.
Study Arms (2)
Open cubital tunnel release
OTHERIn 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 cubital tunnel release
OTHEREndoscopic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr.Lucchina Stefano
Locarno, Canton Ticino, 6600, Switzerland
Related Publications (7)
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.
PMID: 10361850BACKGROUNDMartinoli 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.
PMID: 10994689BACKGROUNDOkamoto 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.
PMID: 10991822BACKGROUNDWatts 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.
PMID: 19695795BACKGROUNDHoffmann 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.
PMID: 16225971BACKGROUNDKing 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.
PMID: 10472009BACKGROUNDChiou 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.
PMID: 9771609RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stefano Lucchina, MD
Ente Ospedaliero Cantonale, Bellinzona
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr., MD
Study Record Dates
First Submitted
April 10, 2016
First Posted
April 15, 2016
Study Start
May 1, 2011
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share