Subcutaneous anterior transposition for Ulnar Nerve Entrapment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Oklahoma, Oklahoma City, OKUlnar Nerve EntrapmentSimple decompression - Procedure
Eligibility
18+
All Sexes
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Study Summary

This trial is comparing two surgeries for ulnar neuropathy and determining which is more effective.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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nerve transfer

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 1 year

1 year
Operative Surgical Procedures
Enrollment, approximately day 0
Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
Up to 1 year
Complication rates for both surgical procedures assessed using a checklist
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
Hand

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Combined serratus anterior plane block and transversus thoracis plane block
2
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Trial Design

2 Treatment Groups

Subcutaneous anterior transposition
1 of 2
Simple decompression
1 of 2

Active Control

378 Total Participants · 2 Treatment Groups

Primary Treatment: Subcutaneous anterior transposition · No Placebo Group · N/A

Subcutaneous anterior transposition
Procedure
ActiveComparator Group · 1 Intervention: Subcutaneous anterior transposition · Intervention Types: Procedure
Simple decompression
Procedure
ActiveComparator Group · 1 Intervention: Simple decompression · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
452 Previous Clinical Trials
1,073,005 Total Patients Enrolled
University of OklahomaOTHER
426 Previous Clinical Trials
97,874 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
56 Previous Clinical Trials
72,879 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,092 Previous Clinical Trials
31,768,922 Total Patients Enrolled
University of MichiganLead Sponsor
1,644 Previous Clinical Trials
6,417,415 Total Patients Enrolled
OrthoCarolina Research Institute, Inc.OTHER
33 Previous Clinical Trials
5,183 Total Patients Enrolled
Emory HealthcareOTHER
5 Previous Clinical Trials
3,010 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,144 Previous Clinical Trials
1,140,055 Total Patients Enrolled
Norton HealthcareOTHER
14 Previous Clinical Trials
2,500 Total Patients Enrolled
Curtis National Hand CenterUNKNOWN
Ohio State UniversityOTHER
728 Previous Clinical Trials
458,661 Total Patients Enrolled
Kevin Chung, MD, MSPrincipal InvestigatorUniversity of Michigan

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed or suspected to have nerve damage in your elbow.
References

Frequently Asked Questions

Are there multiple locations offering this experiment in the state?

"There are 10 research sites authorized to conduct this clinical trial, such as Johns Hopkins University in Baltimore, the OrthoCarolina Research Institute Inc. in Charlotte and the University of Oklahoma located in Oklahoma City, with other approved locations across the US." - Anonymous Online Contributor

Unverified Answer

Are there vacancies left for volunteers to enroll in this experiment?

"According to clinicaltrials.gov, this ongoing medical research project commenced on the 18th of February 2020 and was most recently edited on 12 July 2022. Patients are actively being sought for participation." - Anonymous Online Contributor

Unverified Answer

How many participants are currently being admitted to this medical experiment?

"This clinical trial requires 378 individuals who qualify for the stated inclusion criteria. Patients can partake in this study at either Johns Hopkins University located in Baltimore, Maryland or University of Oklahoma which is situated in Oklahoma City, Oklahoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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