Surgery Techniques for Ulnar Nerve Entrapment

Recruiting at 8 trial locations

Overseen By Sunitha Malay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Previous elbow fracture, Recurrent UNE, Carpal Tunnel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

378 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical techniques to determine which better treats ulnar neuropathy at the elbow, a condition where the ulnar nerve is compressed, causing pain and numbness. The two surgeries are simple decompression, which relieves pressure on the nerve, and subcutaneous anterior transposition, which repositions the nerve for added relief. Individuals diagnosed with ulnar neuropathy at the elbow who have tried other treatments, such as wearing a night splint, may be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to medical knowledge and potentially discover a more effective treatment for their condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques are safe for treating ulnar neuropathy?

Research shows that both surgical techniques under study—simple decompression and subcutaneous anterior transposition—are generally safe for treating ulnar nerve problems at the elbow.

For simple decompression, studies have found this method to be less invasive and effective. Patients report good or excellent results in 89% of cases, with few complications, indicating the procedure is usually well-tolerated.

Similarly, subcutaneous anterior transposition is also considered safe. Research indicates that 87% of patients improve after surgery. One study found no need for additional surgeries or infections, suggesting a low risk of complications.

Both surgeries aim to relieve pressure on the ulnar nerve, reducing pain and improving function. Overall, evidence suggests these procedures are safe and could benefit people with ulnar nerve entrapment at the elbow. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for ulnar nerve entrapment because they offer innovative approaches to relieving nerve pressure. Simple decompression is unique in that it specifically targets and releases the ligamentous structures compressing the ulnar nerve, which can be less invasive. On the other hand, subcutaneous anterior transposition repositions the nerve to a new location in front of the elbow's rotation axis, potentially offering more comprehensive relief by both decompressing and lengthening the nerve. These techniques aim to improve outcomes by addressing the nerve compression in different, potentially more effective ways compared to traditional methods like endoscopic or open decompression.

What evidence suggests that these surgical techniques are effective for ulnar neuropathy?

This trial will compare two surgical techniques for treating ulnar nerve problems at the elbow: simple decompression and subcutaneous anterior transposition. Research has shown that simple decompression, a less invasive method that relieves pressure on the nerve, improves symptoms in about 96.4% of cases, with nearly 90% of patients satisfied with the results. Subcutaneous anterior transposition, which involves moving the nerve to reduce pressure, also proves effective, with 70-90% of patients reporting good to excellent outcomes. Both surgeries benefit people with cubital tunnel syndrome, a condition linked to ulnar nerve issues. ^{2 5 6 7 8}

Who Is on the Research Team?

Kevin Chung, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a specific nerve condition in your elbow, confirmed by tests that measure the speed of nerve signals and muscle responses.

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

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

My UNE has come back after surgery.

Your ulnar nerve is out of place during the preoperative exam.

I have conditions like Carpal Tunnel Syndrome affecting my nerves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo one of two surgical procedures: subcutaneous anterior transposition or simple decompression

1 day

1 visit (in-person)

Post-Surgery Follow-up

Participants are monitored for recovery and complications at various time points

12 months

Visits at 2 weeks, 6 weeks, 3 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Simple decompression
• Subcutaneous anterior transposition

Trial Overview 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.

How Is the Trial Designed?

Group I: Subcutaneous anterior transposition Active Control 1 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 decompression Active Control 1 Intervention

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

Simple decompression is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ulnar Nerve Release for:

• Ulnar neuropathy at the elbow (UNE)
• Cubital tunnel syndrome

Approved in European Union as Ulnar Nerve Release for:

• Ulnar neuropathy at the elbow (UNE)
• Cubital tunnel syndrome

Approved in Canada as Ulnar Nerve Release for:

• Ulnar neuropathy at the elbow (UNE)
• Cubital tunnel syndrome

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Curtis National Hand Center

Collaborator

Trials

1

Recruited

380+

Emory Healthcare

Collaborator

Trials

6

Recruited

1,900+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Norton Healthcare

Collaborator

Trials

17

Recruited

2,900+

OrthoCarolina Research Institute, Inc.

Collaborator

Trials

37

Recruited

6,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The endoscopic decompression technique for ulnar nerve entrapment syndrome was found to be safe and effective, with an 86% success rate in 22 cases, and no intraoperative or postoperative complications reported.

However, the procedure may be more challenging and risky in obese patients due to difficulties in identifying the nerve at the sulcus, suggesting that further research is needed to evaluate this technique compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic decompression of the ulnar nerve at the elbow. Oertel, J., Keiner, D., Gaab, MR.[2010]

In a study of 278 patients with ulnar nerve entrapment, both surgical techniques (subcutaneous transposition and modified submuscular transposition) showed improvements in nerve function after 2 years, indicating their efficacy in treating this condition.

For patients with more severe grades (II and III), the modified submuscular transposition technique resulted in significantly better outcomes compared to subcutaneous transposition, suggesting it is the preferred method for these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of different surgical transposition methods for ulnar nerve entrapment at the elbow. Zhong, W., Zhang, W., Zheng, X., et al.[2017]

In a study involving 10 adult rats, the submuscular method of ulnar nerve anterior transposition resulted in healthier axons compared to the subcutaneous method, indicating better nerve health.

The submuscular technique also led to less perineural scar formation, which could contribute to improved recovery outcomes for patients undergoing this surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Submuscular versus subcutaneous anterior ulnar nerve transposition: a rat histologic study. Lee, SK., Sharma, S., Silver, BA., et al.[2009]

In a study of 31 patients who underwent ulnar nerve decompression and anterior transposition, 100% reported satisfaction with the procedure, indicating it is a safe and effective treatment for ulnar nerve compression.

The procedure resulted in significant improvements in symptoms, with 52% of patients reporting no paresthesia post-surgery, demonstrating its efficacy in restoring function and reducing discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ELBOW ULNAR NEUROPATHY: TREATMENT BY ANTERIOR TRANSPOSITION OF THE ULNAR NERVE. Neder, AT., Alves, RA., Pardini, AG., et al.[2020]

In a study of 81 operations for ulnar nerve entrapment involving 80 patients, 63 cases (87.5%) showed excellent or good outcomes, indicating a high efficacy of the surgical interventions performed.

Using an operating microscope during the procedures appeared to improve outcomes, suggesting that this technique may enhance the effectiveness of ulnar nerve decompression or transposition surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment for ulnar nerve entrapment at the elbow. Asamoto, S., Böker, DK., Jödicke, A.[2022]

The article reviews the causes and mechanisms of ulnar nerve entrapment at the elbow, providing a comprehensive understanding of the condition.

It details a specific surgical technique for anterior submuscular transposition of the ulnar nerve, aimed at achieving reliable outcomes for both first-time and recurrent cases of entrapment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for successful management of ulnar nerve entrapment at the elbow. Dellon, AL.[2022]

In a study of 41 patients with cubital tunnel syndrome, surgical treatment based on ulnar nerve stability—either simple decompression or anterior transposition—resulted in significant improvements in grip strength, pinch strength, and overall function after 2 years.

Factors such as older age, lower preoperative grip strength, and poorer two-point discrimination were linked to less favorable outcomes, highlighting the importance of these metrics in predicting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing Outcomes after Ulnar Nerve Stability-Based Surgery for Cubital Tunnel Syndrome: A Prospective Cohort Study. Kang, HJ., Oh, WT., Koh, IH., et al.[2022]

In a study of 152 participants with ulnar neuropathy, both simple decompression (SD) and anterior subcutaneous transposition (AST) surgeries showed similar clinical outcomes after one year, with no significant difference in effectiveness.

However, the SD procedure had a significantly lower complication rate (9.6%) compared to AST (31.1%), suggesting that SD is a safer and simpler option for treating ulnar nerve issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled study comparing simple decompression versus anterior subcutaneous transposition for idiopathic neuropathy of the ulnar nerve at the elbow: Part 1. Bartels, RH., Verhagen, WI., van der Wilt, GJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4686803/

Results after simple decompression of the ulnar nerve in ... Overall nearly 90% of all patients were satisfied with the result of the operation. In 96.4% of all cases, surgery improved the symptoms and in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2588194/

Simple Decompression of the Ulnar Nerve for Cubital ... Conclusion. Simple decompression of the ulnar nerve is an effective and successful minimally invasive technique for patients with cubital tunnel syndrome.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773396

Safety and Outcomes of Different Surgical Techniques for ... It found that 87% of patients improve with surgery and that open in situ decompression (with or without a medial epicondylectomy) was associated ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024019387

Outcome More Than 20 Years After Surgery for Ulnar ... Good to excellent recovery has been reported in 65%–70% of patients having undergone surgical treatment. In this RCT, 2 surgical approaches are compared: simple ...

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/38239-a-comprehensive-review-of-cubital-tunnel-syndrome

A Comprehensive Review of Cubital Tunnel Syndrome Average grip strength increased following treatment, and 82% of patients with positive provocative ulnar nerve testing achieved resolution.35. A ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686867/

Safety and Outcomes of Different Surgical Techniques for ... It found that 87% of patients improve with surgery and that open in situ decompression (with or without a medial epicondylectomy) was associated ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502313012793

Minimum 6-Year Follow-Up After Ulnar Nerve ... Overall, good or excellent results were achieved in 89% of patients with a low complication rate. Type of study/level of evidence. Therapeutic IV.

8. eymj.org eymj.org/DOIx.php?id=10.3349/ymj.2016.57.2.455

Factors Influencing Outcomes after Ulnar Nerve Stability ... Simple decompression of the ulnar nerve has outcomes similar to anterior transposition for cubital tunnel syndrome; however, there is no ...