Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 100 of 337 for:    Charcot Marie Tooth

Prospective Comparison of Techniques for Cubital Tunnel Release

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02466841
Recruitment Status : Enrolling by invitation
First Posted : June 9, 2015
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh

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.


Condition or disease Intervention/treatment
Cubital Tunnel Syndrome Procedure: Cubital tunnel release

Detailed 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of Techniques for Cubital Tunnel Release
Study Start Date : August 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Group/Cohort Intervention/treatment
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
Patients undergoing cubital tunnel release for ulnar nerve compression at elbow




Primary Outcome Measures :
  1. Patient rated ulnar nerve evaluation (PRUNE) score [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Elbow Range of Motion [ Time Frame: 1 year ]
    The elbow range of motion will be measured in degrees.

  2. Visual Analog Scale (VAS) for Pain [ Time Frame: 1 year ]
    The VAS for pain is a patient-reported single-item scale with scores ranging 0 (no pain) to 10 (worst pain).

  3. 2 Point Discrimination Test [ Time Frame: 1 year ]
    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.

  4. Hand Dynamometer to measure Grip Strength [ Time Frame: 1 year ]
    The Hand Dynamometer is a simple hand-held device when squeezed, will report grip strength in kgs.

  5. Number of subjects with post-surgical complications [ Time Frame: 1 year ]
    The presence or absence of post-surgical complications will be recorded for each subject.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cubital tunnel release
Criteria

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

Publications:
Layout table for additonal information
Responsible Party: John Fowler, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02466841     History of Changes
Other Study ID Numbers: PRO15040063
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries