Cubital Tunnel SyndromeNCT02466841
Prospective Comparison of Techniques for Cubital Tunnel Release
An observational study of Cubital Tunnel Syndrome, run by University of Pittsburgh.
Trial summary
Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Cubital tunnel release
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 1 Nov 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cubital tunnel release
Who may be able to join
- patients indicated to surgery by attending surgeon
Who cannot join
- previous cubital tunnel release on ipsilateral side
- unable/unwilling to provide consent
- pregnant women
- prisoners
- < 18 years of age
About this study
Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve at the elbow, but the ideal release has not been determined. These techniques vary from simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition), and removing part of the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential complications. Simple in-situ release has the benefit of shorter operative times and less surgical dissection, however, the nerve may subluxate post-operatively and cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition) prevent subluxation and take tension off the nerve, however, they require more dissection, larger incisions, and also partially devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a prolonged recovery and persistent pain from removing part of the bone.
The purpose of this study is to prospective evaluate patients undergoing cubital tunnel release according to the standard practice and preference of their surgeon. The investigators plan to compare the different techniques at standard post-operative intervals.
Read the detailed description
Objective:
The purpose of this study is to compare different techniques for cubital tunnel release.
Specific Aims:
- Determine if there are differences in patient-directed outcomes scores between different techniques used for cubital tunnel release.
- Determine if there are differences in post-operative pain scores between different techniques used for cubital tunnel release.
- Determine if there are differences in objective measurements such as range of motion and grip strength scores between different techniques used for cubital tunnel release.
- Determine if there are differences in complications between different techniques used for cubital tunnel release.
Background:
Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve at the elbow, but the ideal release has not been determined. These techniques vary from simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition), and removing part of the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential complications. Simple in-situ release has the benefit of shorter operative times and less surgical dissection, however, the nerve may subluxate post-operatively and cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition) prevent subluxation and take tension off the nerve, however, they require more dissection, larger incisions, and also partially devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a prolonged recovery and persistent pain from removing part of the bone.
Significance:
The results of this study may provide a high level of evidence to determine if specific techniques for cubital tunnel decompression result in improved patient outcomes and/or fewer complications.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Cubital tunnel release
- 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.
Cubital tunnel releaseProcedure or surgery
Patients undergoing cubital tunnel release for ulnar nerve compression at elbow
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cubital tunnel release surgery | Patients undergoing cubital tunnel release surgery will be enrolled. All enrolled subjects will be followed regardless of the technique used by surgeon. Receives: Procedure: Cubital tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated ulnar nerve evaluation (PRUNE) score
The PRUNE is a validated patient rated outcome measurement to assess pain, symptoms and functional disability in patients with ulnar nerve compression at the elbow.
Measured: 1 year
Secondary outcomes (5)
Elbow Range of Motion
The elbow range of motion will be measured in degrees.
Measured: 1 year
Visual Analog Scale (VAS) for Pain
The VAS for pain is a patient-reported single-item scale with scores ranging 0 (no pain) to 10 (worst pain).
Measured: 1 year
2 Point Discrimination Test
The test will measure, in millimeters, the ability of a patient to determine discern the difference between two points when 2 separate instruments are touched to the skin.
Measured: 1 year
Hand Dynamometer to measure Grip Strength
The Hand Dynamometer is a simple hand-held device when squeezed, will report grip strength in kgs.
Measured: 1 year
Number of subjects with post-surgical complications
The presence or absence of post-surgical complications will be recorded for each subject.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startAug 2015
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Could not get any patients to sign up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fowler, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466841
- Sponsor's protocol ID
- PRO15040063
- Status last verified
- Apr 2023
- First submitted
- 3 Jun 2015
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palmer BA, Hughes TB. Cubital tunnel syndrome. J Hand Surg Am. 2010 Jan;35(1):153-63. doi: 10.1016/j.jhsa.2009.11.004.
PubMed 20117320Osei DA, Padegimas EM, Calfee RP, Gelberman RH. Outcomes following modified oblique medial epicondylectomy for treatment of cubital tunnel syndrome. J Hand Surg Am. 2013 Feb;38(2):336-43. doi: 10.1016/j.jhsa.2012.11.006. Epub 2013 Jan 3.
PubMed 23291082MacDermid JC, Grewal R. Development and validation of the patient-rated ulnar nerve evaluation. BMC Musculoskelet Disord. 2013 Apr 26;14:146. doi: 10.1186/1471-2474-14-146.
PubMed 23617407
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Techniques for Cubital Tunnel Release
- ClinicalTrials.gov ID
- NCT02466841
- Acronym / sponsor ID
- PRO15040063
- Conditions
- Cubital Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not get any patients to sign up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve at the elbow, but the ideal release has not been determined. These techniques vary from simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition), and removing part of the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential complications. Simple in-situ release has the benefit of shorter operative times and less surgical dissection, however, the nerve may subluxate post-operatively and cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition) prevent subluxation and take tension off the nerve, however, they require more dissection, larger incisions, and also partially devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a prolonged recovery and persistent pain from removing part of the bone.
The purpose of this study is to prospective evaluate patients undergoing cubital tunnel release according to the standard practice and preference of their surgeon. The investigators plan to compare the different techniques at standard post-operative intervals.
Detailed description
Objective:
The purpose of this study is to compare different techniques for cubital tunnel release.
Specific Aims:
- Determine if there are differences in patient-directed outcomes scores between different techniques used for cubital tunnel release.
- Determine if there are differences in post-operative pain scores between different techniques used for cubital tunnel release.
- Determine if there are differences in objective measurements such as range of motion and grip strength scores between different techniques used for cubital tunnel release.
- Determine if there are differences in complications between different techniques used for cubital tunnel release.
Background:
Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most common compressive neuropathy of the upper extremity (carpal tunnel is the most common). Patients who fail conservative treatment (activity modification, splinting, medications) are offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve at the elbow, but the ideal release has not been determined. These techniques vary from simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition), and removing part of the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential complications. Simple in-situ release has the benefit of shorter operative times and less surgical dissection, however, the nerve may subluxate post-operatively and cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition, sub muscular transposition) prevent subluxation and take tension off the nerve, however, they require more dissection, larger incisions, and also partially devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a prolonged recovery and persistent pain from removing part of the bone.
Significance:
The results of this study may provide a high level of evidence to determine if specific techniques for cubital tunnel decompression result in improved patient outcomes and/or fewer complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cubital tunnel release surgery | – | Procedure: Cubital tunnel releasePatients undergoing cubital tunnel release surgery will be enrolled. All enrolled subjects will be followed regardless of the technique used by surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cubital tunnel release
Key inclusion criteria (1 listed)
- patients indicated to surgery by attending surgeon
Key exclusion criteria (5 listed)
- previous cubital tunnel release on ipsilateral side
- unable/unwilling to provide consent
- pregnant women
- prisoners
- < 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 |
|---|---|---|
| Cubital tunnel releasePatients undergoing cubital tunnel release for ulnar nerve compression at elbow | Procedure or surgery | Patients undergoing cubital tunnel release surgery |
Primary outcome
Patient rated ulnar nerve evaluation (PRUNE) score
Time frame: 1 year
The PRUNE is a validated patient rated outcome measurement to assess pain, symptoms and functional disability in patients with ulnar nerve compression at the elbow.
5 secondary outcomes
Elbow Range of Motion
Time frame: 1 year
Visual Analog Scale (VAS) for Pain
Time frame: 1 year
2 Point Discrimination Test
Time frame: 1 year
Hand Dynamometer to measure Grip Strength
Time frame: 1 year
Number of subjects with post-surgical complications
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 20117320Palmer BA, Hughes TB. Cubital tunnel syndrome. J Hand Surg Am. 2010 Jan;35(1):153-63. doi: 10.1016/j.jhsa.2009.11.004.
- Background: PubMed 23291082Osei DA, Padegimas EM, Calfee RP, Gelberman RH. Outcomes following modified oblique medial epicondylectomy for treatment of cubital tunnel syndrome. J Hand Surg Am. 2013 Feb;38(2):336-43. doi: 10.1016/j.jhsa.2012.11.006. Epub 2013 Jan 3.
- Background: PubMed 23617407MacDermid JC, Grewal R. Development and validation of the patient-rated ulnar nerve evaluation. BMC Musculoskelet Disord. 2013 Apr 26;14:146. doi: 10.1186/1471-2474-14-146.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cubital Tunnel Syndrome, run by University of Pittsburgh.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rated ulnar nerve evaluation (PRUNE) score (time frame: 1 year). 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 NCT02466841, which also lists 3 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 13 Apr 2023.