Presence of the Arcade of Struthers on Preoperative Ultrasound
Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedMarch 19, 2021
March 1, 2021
2 months
November 24, 2020
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of the arcade of Struthers
Presence/visualization of the arcade of Struthers with ultrasound
through study completion, average of 1 day/visit
Study Arms (1)
Participants
EXPERIMENTALPatients diagnosed with cubital tunnel syndrome who are being scheduled for a primary endoscopic cubital tunnel release by the principle investigator will be recruited
Interventions
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
Eligibility Criteria
You may qualify if:
- Diagnosis of Cubital tunnel syndrome
- Planned for endoscopic cubital tunnel release primary surgery
- \>=18 years of age
- no previous arm or elbow surgeries
You may not qualify if:
- Revision surgery
- Planned for open cubital tunnel release
- Prior surgical intervention around the arm or the elbow
- \<18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Christine M Kleinert Institute
Louisville, Kentucky, 40202, United States
Kleinert Kutz & Associates
Louisville, Kentucky, 40202, United States
Related 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.
PMID: 30140129RESULTStaples 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.
PMID: 28953087RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuna Ozyurekoglu, MD
President, Christine M Kleinert Institute for Hand and Microsurgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 8, 2020
Study Start
March 31, 2021
Primary Completion
May 31, 2021
Study Completion
July 31, 2021
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
No plan to share with other researchers