Sonographic Examination Cubital Tunnel Release (SPECTRE)
Primary Purpose
Ulnar Nerve Compression, Cubital Tunnel
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Cubital tunnel release
Sponsored by
About this trial
This is an interventional treatment trial for Ulnar Nerve Compression, Cubital Tunnel focused on measuring Ulnar Nerve Compression, Cubital Tunnel
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.
Sites / Locations
- Dr.Lucchina Stefano
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Open cubital tunnel release
Endoscopic cubital tunnel release
Arm Description
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.
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Society Function Score
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
Secondary Outcome Measures
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
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.
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)
Full Information
NCT ID
NCT02739945
First Posted
April 10, 2016
Last Updated
April 14, 2016
Sponsor
Ente Ospedaliero Cantonale, Bellinzona
1. Study Identification
Unique Protocol Identification Number
NCT02739945
Brief Title
Sonographic Examination Cubital Tunnel Release
Acronym
SPECTRE
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ente Ospedaliero Cantonale, Bellinzona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Nerve Compression, Cubital Tunnel
Keywords
Ulnar Nerve Compression, Cubital Tunnel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open cubital tunnel release
Arm Type
Other
Arm Description
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.
Arm Title
Endoscopic cubital tunnel release
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cubital tunnel release
Intervention Description
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.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Society Function Score
Description
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
Time Frame
12 months postoperatively.
Secondary Outcome Measure Information:
Title
Jamar dynamometer (grip strength)
Description
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
Time Frame
12 months postoperatively.
Title
Static-2 point discrimination test
Description
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.
Time Frame
12 months postoperatively.
Title
4-point Likert-type scale
Description
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)
Time Frame
12 months postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Lucchina, MD
Organizational Affiliation
Ente Ospedaliero Cantonale, Bellinzona
Official's Role
Study Director
Facility Information:
Facility Name
Dr.Lucchina Stefano
City
Locarno
State/Province
Canton Ticino
ZIP/Postal Code
6600
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10361850
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.
Results Reference
background
PubMed Identifier
10994689
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.
Results Reference
background
PubMed Identifier
10991822
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.
Results Reference
background
PubMed Identifier
19695795
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.
Results Reference
background
PubMed Identifier
16225971
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.
Results Reference
background
PubMed Identifier
10472009
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.
Results Reference
background
PubMed Identifier
9771609
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.
Results Reference
result
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Sonographic Examination Cubital Tunnel Release
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