Prospective Comparison of Techniques for Cubital Tunnel Release

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Comparison of Techniques for Cubital Tunnel Release

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Procedure: Cubital tunnel release


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing cubital tunnel release surgery<br>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<br>* Patients undergoing cubital tunnel release for ulnar nerve compression at elbow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elbow Range of Motion | The elbow range of motion will be measured in degrees. | 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). | 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. | 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. | 1 year | 
| Number of subjects with post-surgical complications | The presence or absence of post-surgical complications will be recorded for each subject. | 1 year |