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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02739945 |
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Date of registration:
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10/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sonographic Examination Cubital Tunnel Release
SPECTRE |
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Scientific title:
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Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02739945 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Stefano Lucchina, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ente Ospedaliero Cantonale, Bellinzona |
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Key inclusion & exclusion criteria
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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.
Age minimum:
35 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulnar Nerve Compression, Cubital Tunnel
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Intervention(s)
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Procedure: Cubital tunnel release
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Primary Outcome(s)
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American Shoulder and Elbow Society Function Score
[Time Frame: 12 months postoperatively.]
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Secondary Outcome(s)
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Jamar dynamometer (grip strength)
[Time Frame: 12 months postoperatively.]
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4-point Likert-type scale
[Time Frame: 12 months postoperatively.]
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Static-2 point discrimination test
[Time Frame: 12 months postoperatively.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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