What side effects are associated with this type of intervention?

The most common treatments for Ulnar Nerve Entrapment include decompression and transposition of the ulnar nerve. Known side effects of these surgical procedures can include infection, bleeding, and nerve damage, which may result in numbness, tingling, or weakness in the hand and forearm. Additionally, there may be scarring and a risk of recurrence of symptoms. Postoperative pain and swelling are also common but typically resolve with time.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Ulnar Nerve Entrapment (UNE) that directly correlate with the surgical procedures of decompression or transposition of the ulnar nerve. Treatment for UNE typically involves conservative management such as physical therapy, splinting, and anti-inflammatory medications. When these measures fail, surgical options like decompression or transposition are considered. These surgical procedures aim to relieve pressure on the ulnar nerve and improve symptoms, and they are the focus of ongoing clinical research to determine their efficacy.

What other types of research exist?

Promising, novel alternatives to surgical procedures for ulnar nerve entrapment include: <ol> <li>Autologous tenocyte injection: This investigational procedure aims to promote healing by injecting autologous tenocytes.</li> <li></li> </ol> Prolotherapy: Involves injecting a local irritant to elicit an inflammatory response, potentially effective in chronic musculoskeletal injuries. 3. Sclerosing polidocanol injection: Targets neovessels to reduce pain associated with chronic tendinopathy. 4. Topical nitroglycerin: May improve tendon healing by stimulating collagen synthesis. 5. Ultrasound-guided percutaneous needle tenotomy: Uses a needle to fenestrate tendinotic tissue and break up calcifications under ultrasound guidance.

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Surgery Techniques for Ulnar Nerve Entrapment

N/A

Recruiting

Led By Kevin Chung, MD, MS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow

Able to read, understand and complete the questionnaires in English

Must not have

Recurrent UNE after previous surgery

Participants with severe comorbid conditions that prohibit surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine which of two surgeries is more effective in treating ulnar neuropathy at the elbow and reducing symptoms.

Who is the study for?

This trial is for people with ulnar nerve entrapment at the elbow who have tried non-surgical treatments like night splinting. They must meet specific diagnostic criteria and be able to follow study procedures. It's not for those with previous elbow surgery, other neuropathies, or conditions that make surgery too risky.

What is being tested?

The study compares two surgeries: 'simple decompression' and 'subcutaneous anterior transposition,' to see which one better relieves symptoms of ulnar neuropathy at the elbow. Participants will be randomly assigned to one of these surgical options.

What are the potential side effects?

Potential side effects from both surgeries may include pain at the surgery site, infection risk, numbness or weakness in the hand or arm, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have or might have a pinched nerve in my elbow.

Select...

I can read, understand, and fill out questionnaires in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My UNE has come back after surgery.

Select...

I cannot undergo surgery due to severe health conditions.

Select...

I had surgery for a broken elbow in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Operative Surgical Procedures

Secondary study objectives

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

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Subcutaneous anterior transpositionActive Control1 Intervention

Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation

Group II: Simple decompressionActive Control1 Intervention

In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulnar Nerve Entrapment include decompression and transposition surgeries. Decompression involves relieving pressure on the ulnar nerve by removing any constrictive tissues or structures, which helps to restore normal nerve function and alleviate symptoms. Transposition surgery involves relocating the ulnar nerve to a position where it is less likely to be compressed or irritated, often moving it from behind the medial epicondyle to a more anterior position. These treatments are crucial for patients as they directly address the mechanical compression of the nerve, which is the primary cause of pain, numbness, and muscle weakness associated with Ulnar Nerve Entrapment. By alleviating this pressure, these surgical interventions can significantly improve nerve function and patient quality of life.