Prospective Comparison of Techniques for Cubital Tunnel Release

Cubital Tunnel Syndrome Clinical Trial

Official title:

Prospective Comparison of Techniques for Cubital Tunnel Release

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02466841
• Other study ID #: PRO15040063
• Status: Withdrawn
• Start date: August 2015
• Est. completion date: November 1, 2019

Study information

• Verified date: April 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome

Intervention

Procedure:
• Cubital tunnel release
Patients undergoing cubital tunnel release for ulnar nerve compression at elbow

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

References & Publications (3)

MacDermid 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. — View Citation

Osei 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Elbow Range of Motion	The elbow range of motion will be measured in degrees.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of subjects with post-surgical complications	The presence or absence of post-surgical complications will be recorded for each subject.	1 year