Prospective Comparison of Techniques for Cubital Tunnel Release

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrical Nerve Stimulation of the Ulnar Nerve

NCT02566616

Cubital Tunnel Syndrome

WITHDRAWN NA

Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

NCT03629470

Cubital Tunnel Syndrome

COMPLETED NA

Randomized Trial of Supercharged End-to-Side Anterior Interosseous Nerve Transfer for Severe Cubital Tunnel Syndrome

NCT04647058

Cubital Tunnel Syndrome Ulnar Nerve Compression Ulnar Nerve Palsy +5 more

WITHDRAWN NA

Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

NCT01893164

Cubital Tunnel Syndrome

UNKNOWN NA

Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow

NCT02281656

Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cubital Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.