Presence of the Arcade of Struthers on Preoperative Ultrasound

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ClinicalTrials.gov Identifier: NCT04658511

Recruitment Status : Not yet recruiting

First Posted : December 8, 2020

Last Update Posted : March 19, 2021

See Contacts and Locations

Sponsor:

Collaborator:

Kleinert, Kutz and Associates

Information provided by (Responsible Party):

Christine M. Kleinert Institute for Hand and Microsurgery

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
Cubital Tunnel Syndrome	Device: Ultrasound	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Study Start Date :	March 31, 2021
Estimated Primary Completion Date :	May 31, 2021
Estimated Study Completion Date :	July 31, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

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 :

Presence of the arcade of Struthers [ Time Frame: through study completion, average of 1 day/visit ]
Presence/visualization of the arcade of Struthers with ultrasound

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658511

Contacts

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Contact: Wassim Mourad, MD	(267) 588-7344	wmourad@kleinertkutz.com
Contact: Julianne Sutton, MPH	502-562-0390	jsutton@kleinertkutz.com

Locations

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United States, Kentucky
Christine M Kleinert Institute
Louisville, Kentucky, United States, 40202
Contact: Tuna Ozyurekoglu, MD 502-777-0444 tozyurekoglu@kleinertkutz.com
Contact: Julianne Sutton, MPH 502-562-0390 jsutton@kleinertkutz.com
Principal Investigator: Tuna Ozyurekoglu, MD
Sub-Investigator: Wassim Mourad, MD
Sub-Investigator: Jeffrey Jett, MD
Kleinert Kutz & Associates
Louisville, Kentucky, United States, 40202
Contact: Tuna Ozyurekoglu, MD 502-777-0444 tozyurekoglu@kleinertkutz.com
Contact: Julianne Sutton, MPH 502-562-0390 jsutton@kleinertkutz.com
Principal Investigator: Tuna Ozyurekoglu, MD
Sub-Investigator: Wassim Mourad, MD
Sub-Investigator: Jeffrey Jett, MD

Sponsors and Collaborators

Christine M. Kleinert Institute for Hand and Microsurgery

Kleinert, Kutz and Associates

Investigators

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

More Information

Publications of Results:

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. Erratum in: J Orthop. 2020 Dec 14;23:275.

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.

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Responsible Party:	Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:	NCT04658511
Other Study ID Numbers:	20.1097
First Posted:	December 8, 2020 Key Record Dates
Last Update Posted:	March 19, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No plan to share with other researchers

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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:


arcade of struthers cubital tunnel

Additional relevant MeSH terms:

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Cubital Tunnel Syndrome Ulnar Neuropathies Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases	Ulnar Nerve Compression Syndromes Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

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