Sonographic Examination Cubital Tunnel Release (SPECTRE)

Ente Ospedaliero Cantonale, Bellinzona

Status and phase: Completed; Phase 3

Conditions: Ulnar Nerve Compression, Cubital Tunnel

Treatments: Procedure: Cubital tunnel release

Study type: Interventional

Funder types: Other

Identifiers

NCT02739945

EnteOC

Details and patient eligibility

About

The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Open cubital tunnel release

Other group

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.

Treatment:

Procedure: Cubital tunnel release

Endoscopic cubital tunnel release

Other group

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.

Treatment:

Procedure: Cubital tunnel release