Sonographic Examination Cubital Tunnel Release

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Ulnar Nerve Compression, Cubital Tunnel

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open cubital tunnel release

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.

Group Type OTHER

Cubital tunnel release

Intervention Type PROCEDURE

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.

Endoscopic cubital tunnel release

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.

Group Type OTHER

Cubital tunnel release

Intervention Type PROCEDURE

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.

Interventions

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Cubital tunnel release

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes