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| ID | Type | Description | Link |
|---|---|---|---|
| U01AR073485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Curtis National Hand Center | UNKNOWN |
| Emory Healthcare | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple decompression | Active Comparator | In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve. |
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| Subcutaneous anterior transposition | Active Comparator | Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple decompression | Procedure | Surgical technique |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score | The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales assessing overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. Scores range from 0-100, 100=no disability). In the pain scale, however, high scores indicate greater pain (0-100, 0=no pain). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score | The MHQ is a self-report measure that assesses the function of hand(s) and/or wrist(s). The MHQ contains six distinct scales. The score will be measured at various time points to identify the recovery trend.In a pain scale, high scores indicate greater pain (0-100, 0=no pain) | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunitha Malay | Contact | 734-763-1834 | smalay@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Chung, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare | Recruiting | Atlanta | Georgia | 30329 | United States |
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| Norton Healthcare |
| OTHER |
| Ohio State University | OTHER |
| OrthoCarolina Research Institute, Inc. | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| Wake Forest University Health Sciences | OTHER |
| Johns Hopkins University | OTHER |
| University of Oklahoma | OTHER |
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.
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double-blinded
| Subcutaneous anterior transposition | Procedure | Surgical technique |
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| Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score | The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms. The score will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score | The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms. The score will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer | Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge | Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand) | Thresholds on the tip of the finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacing's are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." The threshold difference will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand) | A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes. Interpretation scale for monofilaments: 2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only Sensory thresholds will be measured at various time points to identify the recovery trend. | Up to 1 year |
| Complication rates for both surgical procedures assessed using a checklist | Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits. | Up to 1 year |
| Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale | Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability. | Enrollment, approximately day 0 |
| Norton Healthcare | Recruiting | Louisville | Kentucky | 40241 | United States |
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| Johns Hopkins University | Terminated | Baltimore | Maryland | 21093 | United States |
| Curtis National Hand Center | Recruiting | Baltimore | Maryland | 21218 | United States |
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| Michigan Medicine | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| OrthoCarolina Research Institute, Inc. | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73126 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D020424 | Ulnar Neuropathies |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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