Clinical trial NCT04254185: Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Official title: Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy Ulnar
Keywords: Decompression
Anterior Subcutaneous Transposition
Elbow
Ulnar Nerve
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Curtis National Hand Center
name: Emory Healthcare
name: Norton Healthcare
name: Ohio State University
name: OrthoCarolina Research Institute, Inc.
name: University of Pittsburgh Medical Center
name: Wake Forest University Health Sciences
name: Johns Hopkins University
name: University of Oklahoma
First posted: 2020-02-05
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double-blind, multicenter, phase 3, randomized controlled superiority trial examining the treatment effectiveness of in-situ decompression and subcutaneous anterior transposition for UNE.
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score
timeFrame: 1 year
Secondary outcomes:
measure: Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
timeFrame: Up to 1 year
measure: Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
timeFrame: Up to 1 year
measure: Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
timeFrame: Up to 1 year
measure: Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
timeFrame: Up to 1 year
measure: Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
timeFrame: Up to 1 year
measure: Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)
timeFrame: Up to 1 year
measure: Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)
timeFrame: Up to 1 year
measure: Complication rates for both surgical procedures assessed using a checklist
timeFrame: Up to 1 year
measure: Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
timeFrame: Enrollment, approximately day 0
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Curtis National Hand Center
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Kevin Chung, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: