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Completed

NCT Number: NCT02739945

Sonographic Examination Cubital Tunnel Release

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cubital tunnel release

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.

Primary outcomes

  1. American Shoulder and Elbow Society Function Score

    Time frame: 12 months postoperatively.

    Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale

Secondary outcomes

  1. Jamar dynamometer (grip strength)

    Time frame: 12 months postoperatively.

    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

  2. Static-2 point discrimination test

    Time frame: 12 months postoperatively.

    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.

  3. 4-point Likert-type scale

    Time frame: 12 months postoperatively.

    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)

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study

Acronym: SPECTRE

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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