Presence of the Arcade of Struthers on Preoperative Ultrasound

NCT ID: NCT04658511

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cubital Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kleinert, Kutz and Associates

OTHER

Sponsor Role collaborator

Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tuna Ozyurekoglu, MD

Role: PRINCIPAL_INVESTIGATOR

President, Christine M Kleinert Institute for Hand and Microsurgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Christine M Kleinert Institute

Louisville, Kentucky, United States

Site Status

Kleinert Kutz & Associates

Louisville, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wassim Mourad, MD

Role: CONTACT

(267) 588-7344

Julianne Sutton, MPH

Role: CONTACT

502-562-0390

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tuna Ozyurekoglu, MD

Role: primary

502-777-0444

Julianne Sutton, MPH

Role: backup

502-562-0390

Tuna Ozyurekoglu, MD

Role: primary

502-777-0444

Julianne Sutton, MPH

Role: backup

502-562-0390

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 30140129 (View on PubMed)

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.

Reference Type RESULT
PMID: 28953087 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20.1097

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AIN Transfer for Cubital Tunnel Syndrome
NCT05242302 COMPLETED PHASE1/PHASE2
Wrist Arthroscopy Study
NCT04457362 COMPLETED NA