Prospective Comparison of Techniques for Cubital Tunnel Release

April 12, 2023 updated by: John Fowler, University of Pittsburgh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective:

The purpose of this study is to compare different techniques for cubital tunnel release.

Specific Aims:

  1. Determine if there are differences in patient-directed outcomes scores between different techniques used for cubital tunnel release.
  2. Determine if there are differences in post-operative pain scores between different techniques used for cubital tunnel release.
  3. 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.
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cubital tunnel release

Description

Inclusion Criteria:

  • patients indicated to surgery by attending surgeon

Exclusion Criteria:

  • previous cubital tunnel release on ipsilateral side
  • unable/unwilling to provide consent
  • pregnant women
  • prisoners
  • < 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Cubital tunnel release
Patients undergoing cubital tunnel release for ulnar nerve compression at elbow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Elbow Range of Motion
Time Frame: 1 year
The elbow range of motion will be measured in degrees.
1 year
Visual Analog Scale (VAS) for Pain
Time Frame: 1 year
The VAS for pain is a patient-reported single-item scale with scores ranging 0 (no pain) to 10 (worst pain).
1 year
2 Point Discrimination Test
Time Frame: 1 year
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.
1 year
Hand Dynamometer to measure Grip Strength
Time Frame: 1 year
The Hand Dynamometer is a simple hand-held device when squeezed, will report grip strength in kgs.
1 year
Number of subjects with post-surgical complications
Time Frame: 1 year
The presence or absence of post-surgical complications will be recorded for each subject.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO15040063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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