Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- American Shoulder and Elbow Society Function Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- Static-2 point discrimination test(12 months postoperatively.)
- 4-point Likert-type scale(12 months postoperatively.)
- Jamar dynamometer (grip strength)(12 months postoperatively.)
Investigators
Marco Guidi
Dr., MD
Ente Ospedaliero Cantonale, Bellinzona