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Sonographic Examination Cubital Tunnel Release (SPECTRE)

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ClinicalTrials.gov Identifier: NCT02739945
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Marco Guidi, Ente Ospedaliero Cantonale, Bellinzona

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

Condition or disease Intervention/treatment Phase
Ulnar Nerve Compression, Cubital Tunnel Procedure: Cubital tunnel release Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
Study Start Date : May 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
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.
Procedure: 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.

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.
Procedure: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739945


Locations
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Switzerland
Dr.Lucchina Stefano
Locarno, Canton Ticino, Switzerland, 6600
Sponsors and Collaborators
Ente Ospedaliero Cantonale, Bellinzona
Investigators
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Study Director: Stefano Lucchina, MD Ente Ospedaliero Cantonale, Bellinzona

Publications of Results:
Other Publications:
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Responsible Party: Marco Guidi, Dr., MD, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT02739945     History of Changes
Other Study ID Numbers: EnteOC
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marco Guidi, Ente Ospedaliero Cantonale, Bellinzona:
Ulnar Nerve Compression, Cubital Tunnel

Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries