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Sonographic Examination Cubital Tunnel Release

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02739945
Acronym
SPECTRE
Enrollment
60
Registered
2016-04-15
Start date
2011-05-31
Completion date
2016-04-30
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulnar Nerve Compression, Cubital Tunnel

Keywords

Ulnar Nerve Compression, Cubital Tunnel

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.

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.

Interventions

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.

Sponsors

Ente Ospedaliero Cantonale, Bellinzona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
American Shoulder and Elbow Society Function Score12 months postoperatively.Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale

Secondary

MeasureTime frameDescription
Static-2 point discrimination test12 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.
Jamar dynamometer (grip strength)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
4-point Likert-type scale12 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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026