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Presence of the Arcade of Struthers on Preoperative Ultrasound

Primary Purpose

Cubital Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Christine M. Kleinert Institute for Hand and Microsurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring arcade of struthers, cubital tunnel

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christine M Kleinert Institute
  • Kleinert Kutz & Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

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

Outcomes

Primary Outcome Measures

Presence of the arcade of Struthers
Presence/visualization of the arcade of Struthers with ultrasound

Secondary Outcome Measures

Full Information

First Posted
November 24, 2020
Last Updated
March 18, 2021
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Kleinert, Kutz and Associates
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1. Study Identification

Unique Protocol Identification Number
NCT04658511
Brief Title
Presence of the Arcade of Struthers on Preoperative Ultrasound
Official Title
Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2021 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Kleinert, Kutz and Associates

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
Keywords
arcade of struthers, cubital tunnel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Patients diagnosed with cubital tunnel syndrome who are being scheduled for a primary endoscopic cubital tunnel release by the principle investigator will be recruited
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Presence of the arcade of Struthers
Description
Presence/visualization of the arcade of Struthers with ultrasound
Time Frame
through study completion, average of 1 day/visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wassim Mourad, MD
Phone
(267) 588-7344
Email
wmourad@kleinertkutz.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne Sutton, MPH
Phone
502-562-0390
Email
jsutton@kleinertkutz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
Organizational Affiliation
President, Christine M Kleinert Institute for Hand and Microsurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine M Kleinert Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
Phone
502-777-0444
Email
tozyurekoglu@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Julianne Sutton, MPH
Phone
502-562-0390
Email
jsutton@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
First Name & Middle Initial & Last Name & Degree
Wassim Mourad, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Jett, MD
Facility Name
Kleinert Kutz & Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
Phone
502-777-0444
Email
tozyurekoglu@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Julianne Sutton, MPH
Phone
502-562-0390
Email
jsutton@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
First Name & Middle Initial & Last Name & Degree
Wassim Mourad, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Jett, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share with other researchers
Citations:
PubMed Identifier
30140129
Citation
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. Erratum In: J Orthop. 2020 Dec 14;23:275.
Results Reference
result
PubMed Identifier
28953087
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.
Results Reference
result

Learn more about this trial

Presence of the Arcade of Struthers on Preoperative Ultrasound

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