Study Stopped
Could not get any patients to sign up
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2015
Actual (reported)June 9, 2015
Actual (reported)August 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 2019
Actual (reported)November 1, 2019
Actual (reported)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
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
Patients undergoing cubital tunnel release surgery will be enrolled. All enrolled subjects will be followed regardless of the technique used by surgeon.
Patients undergoing cubital tunnel release for ulnar nerve compression at elbow
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing cubital tunnel release
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.
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.
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.
0 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2015
First Posted
June 9, 2015
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of ESWT for Cubital Tunnel Syndrome
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)Last Updated
April 13, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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