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Recruiting NCT04254185

Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

No phase Interventional Neuropathy Ulnar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simple decompression, Subcutaneous anterior transposition.
Who it may be relevant to
Registry conditions: Neuropathy Ulnar. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. This research will determine if one surgery is better than the other to alleviate symptoms.

Interventions

  • Procedure Simple decompression
    Surgical technique
  • Procedure Subcutaneous anterior transposition
    Surgical technique

Primary outcome measures

  • Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score [Time frame: 1 year]
Secondary outcome measures (9)
  • Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score [Time frame: Up to 1 year]
  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score [Time frame: Up to 1 year]
  • Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score [Time frame: Up to 1 year]
  • Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer [Time frame: Up to 1 year]
  • Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge [Time frame: Up to 1 year]
  • Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand) [Time frame: Up to 1 year]
  • Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand) [Time frame: Up to 1 year]
  • Complication rates for both surgical procedures assessed using a checklist [Time frame: Up to 1 year]
  • Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale [Time frame: Enrollment, approximately day 0]

Eligibility criteria

Inclusion criteria

  • A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow
  • Confirmation of ulnar neuropathy using the American Association of Electrodiagnostic Medicine criteria for electrodiagnostic studies at the elbow. (Participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segment greater than 10 m/s slower than BE to wrist segment; A decrease in compound muscle action potential (CMAP) negative peak amplitude from BE to AE greater than 20%)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Able to read, understand and complete the questionnaires in English

Exclusion criteria

  • Previous elbow fracture requiring surgical fixation
  • Patients who have not attempted conservative management for UNE (e.g. night splinting)
  • Subluxation of ulnar nerve on preoperative exam
  • Recurrent UNE after previous surgery
  • Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities
  • Participants with severe comorbid conditions that prohibit surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Emory Healthcare — Atlanta
  • Norton Healthcare — Louisville
  • Johns Hopkins University — Baltimore
  • Curtis National Hand Center — Baltimore
  • Michigan Medicine — Ann Arbor
  • OrthoCarolina Research Institute, Inc. — Charlotte
  • Wake Forest University Health Sciences — Winston-Salem
  • Ohio State University — Columbus
  • … and 2 more centers

Identifiers

NCT: NCT04254185 · HUM00133613 · U01AR073485

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗