Sonographic Examination Cubital Tunnel Release

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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Ulnar Nerve Compression, Cubital Tunnel

Intervention / Treatment
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* Procedure: Cubital tunnel release


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open cubital tunnel release<br>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. | Procedure: Cubital tunnel release<br>* 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.<br>|
| Other: Endoscopic cubital tunnel release<br>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. | Procedure: Cubital tunnel release<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Society Function Score | Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale | 12 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months postoperatively. | 
| 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. | 12 months postoperatively. | 
| 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) | 12 months postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulnar Nerve Compression, Cubital Tunnel