Prospective Comparison of Techniques for Cubital Tunnel Release

NCT02466841 | Withdrawn DMC

• 1 other identifier: PRO15040063
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Elbow Range of Motion

  1 year

• Visual Analog Scale (VAS) for Pain

  1 year

• 2 Point Discrimination Test

  1 year

• Hand Dynamometer to measure Grip Strength

  1 year

• Number of subjects with post-surgical complications

  1 year

Study Arms (1)

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

Interventions

Cubital tunnel release PROCEDURE

Patients undergoing cubital tunnel release for ulnar nerve compression at elbow

Patients undergoing cubital tunnel release surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cubital tunnel release

You may qualify if:

• patients indicated to surgery by attending surgeon

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (3)

• 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.

  PMID: 20117320 BACKGROUND

• 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.

  PMID: 23291082 BACKGROUND

• 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.

  PMID: 23617407 BACKGROUND

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 13, 2023

Record last verified: 2023-04