Presence of the Arcade of Struthers on Preoperative Ultrasound

Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04658511
Collaborator
Kleinert, Kutz and Associates (Other)
25
2
1
4
12.5
3.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery
Anticipated Study Start Date :
Mar 31, 2021
Anticipated Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants

Patients diagnosed with cubital tunnel syndrome who are being scheduled for a primary endoscopic cubital tunnel release by the principle investigator will be recruited

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

Outcome Measures

Primary Outcome Measures

  1. Presence of the arcade of Struthers [through study completion, average of 1 day/visit]

    Presence/visualization of the arcade of Struthers with ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christine M Kleinert Institute Louisville Kentucky United States 40202
2 Kleinert Kutz & Associates Louisville Kentucky United States 40202

Sponsors and Collaborators

  • Christine M. Kleinert Institute for Hand and Microsurgery
  • Kleinert, Kutz and Associates

Investigators

  • Principal Investigator: Tuna Ozyurekoglu, MD, President, Christine M Kleinert Institute for Hand and Microsurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT04658511
Other Study ID Numbers:
  • 20.1097
First Posted:
Dec 8, 2020
Last Update Posted:
Mar 19, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2021