Cubital Tunnel SyndromeNCT04658511
Presence of the Arcade of Struthers on Preoperative Ultrasound
A study testing Ultrasound in people with Cubital Tunnel Syndrome, run by Christine M. Kleinert Institute for Hand and Microsurgery at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Cubital tunnel syndrome
- Planned for endoscopic cubital tunnel release primary surgery
- >=18 years of age
- no previous arm or elbow surgeries
Who cannot join
- Revision surgery
- Planned for open cubital tunnel release
- Prior surgical intervention around the arm or the elbow
- <18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Christine M Kleinert Institute
Louisville, Kentucky, 40202
Tuna Ozyurekoglu, MD, 502-777-0444, tozyurekoglu@kleinertkutz.com
Julianne Sutton, MPH, 502-562-0390, jsutton@kleinertkutz.com
Kleinert Kutz & Associates
Louisville, Kentucky, 40202
Tuna Ozyurekoglu, MD, 502-777-0444, tozyurekoglu@kleinertkutz.com
Julianne Sutton, MPH, 502-562-0390, jsutton@kleinertkutz.com
About this study
Official title: Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery
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.
Read the 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.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Ultrasound
- Keywords
- arcade of struthers, cubital tunnel
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Patients diagnosed with cubital tunnel syndrome who are being scheduled for a primary endoscopic cubital tunnel release by the principle investigator will be recruited Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of the arcade of Struthers
Presence/visualization of the arcade of Struthers with ultrasound
Measured: through study completion, average of 1 day/visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start31 Mar 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Collaborators
- Kleinert, Kutz and Associates
- Responsible party
- Sponsor
- Investigators
- Tuna Ozyurekoglu, MD, Principal investigator, President, Christine M Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658511
- Sponsor's protocol ID
- 20.1097
- Status last verified
- Mar 2021
- First submitted
- 24 Nov 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share with other researchers
Publications
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.
PubMed 30140129Staples 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.
PubMed 28953087
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT04658511
- Acronym / sponsor ID
- 20.1097
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- arcade of struthers, cubital tunnel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Collaborators
- Kleinert, Kutz and Associates
- Study start
- 31 Mar 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: UltrasoundPatients diagnosed with cubital tunnel syndrome who are being scheduled for a primary endoscopic cubital tunnel release by the principle investigator will be recruited |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Cubital tunnel syndrome
- Planned for endoscopic cubital tunnel release primary surgery
- >=18 years of age
- no previous arm or elbow surgeries
Key exclusion criteria (4 listed)
- Revision surgery
- Planned for open cubital tunnel release
- Prior surgical intervention around the arm or the elbow
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundOn the spot, during the pre-op clinic visit, an ultrasound exam will be done by the PI trying to visualize the arcade of Struthers | Device | Participants |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Results publication: PubMed 30140129Andrews 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.
- Results publication: PubMed 28953087Staples 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.
- Individual participant dataSharing planned: No. No plan to share with other researchers
Related trials for Cubital Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuna Ozyurekoglu, MD principal investigator
President, Christine M Kleinert Institute for Hand and Microsurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Cubital Tunnel Syndrome, run by Christine M. Kleinert Institute for Hand and Microsurgery at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wassim Mourad, MD ((267) 588-7344, wmourad@kleinertkutz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of the arcade of Struthers (time frame: through study completion, average of 1 day/visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04658511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.