Presence of the Arcade of Struthers on Preoperative Ultrasound

Cubital Tunnel Syndrome Clinical Trial

Official title:

Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658511
• Other study ID #: 20.1097
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: Wassim Mourad, MD
• Phone: (267) 588-7344
• Email: wmourad[@]kleinertkutz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the correlation between the presence of the arcade of Struthers on preoperative ultrasound and during endoscopic surgery for cubital tunnel syndrome, and to determine the reliability of a portable ultrasound probe to detect the arcade of Struthers in the arm.

Description:

The ulnar nerve comes from the medical cord of the brachial plexus (C8-T1). It travels out of the axilla along the medial border of the arm to pass into the forearm via the cubital tunnel at the elbow. Cubital tunnel syndrome is the result of compression and traction on the ulnar nerve about the elbow, which can occur at multiple sites. The most proximal possible site of compression causing is the arcade of Struthers. This entity has been described as an aponeurotic band, as a fibrous canal or as thickened connective tissue. Regardless of the nomenclature, ulnar nerve compression has been documented at the location of the arcade of Struthers, which is 6 to 10 cm proximal to the medial epicondyle. Simple open in situ decompression typically results in decompression of the ulnar nerve 6 cm proximal and 6 cm distal to the medial epicondyle while endoscopic ulnar nerve decompression decompresses on average 17 cm of the ulnar nerve (range 25-23 cm), thus consistently reaching the area of the arcade of Struthers. Recurrent cubital tunnel syndrome after simple decompression can be due failure to the release of the arcade of Struthers, and the revision surgery involved extending the incision and length of ulnar nerve release. With the advances in ultrasound imaging, the identification of the arcade of Struthers in mid arm is feasible. hence, it would be beneficial to identify the presence and the location of the arcade of Struthers pre-operatively, to direct the surgical procedure to decompress the ulnar nerve more proximally in cases of a simple decompression in situ.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Cubital tunnel syndrome

• Planned for endoscopic cubital tunnel release primary surgery

• >=18 years of age

• no previous arm or elbow surgeries

Exclusion Criteria:

• Revision surgery

• Planned for open cubital tunnel release

• Prior surgical intervention around the arm or the elbow

• <18 years of age

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome

Intervention

Device:
• Ultrasound
On the spot, during the pre-op clinic visit, an ultrasound exam will be done by the PI trying to visualize the arcade of Struthers

Locations

Country	Name	City	State
United States	Christine M Kleinert Institute	Louisville	Kentucky
United States	Kleinert Kutz & Associates	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery	Kleinert, Kutz and Associates

Country where clinical trial is conducted

United States, 

References & Publications (2)

Andrews K, Rowland A, Pranjal A, Ebraheim N. Cubital tunnel syndrome: Anatomy, clinical presentation, and management. J Orthop. 2018 Aug 16;15(3):832-836. doi: 10.1016/j.jor.2018.08.010. eCollection 2018 Sep. Review. — View Citation

Staples JR, Calfee R. Cubital Tunnel Syndrome: Current Concepts. J Am Acad Orthop Surg. 2017 Oct;25(10):e215-e224. doi: 10.5435/JAAOS-D-15-00261. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of the arcade of Struthers	Presence/visualization of the arcade of Struthers with ultrasound	through study completion, average of 1 day/visit