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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment for ulnar nerve entrapment?

Research shows that both simple decompression and anterior transposition are effective treatments for ulnar nerve entrapment at the elbow. Studies indicate that simple decompression can be as effective as anterior transposition, especially for less severe cases, while modified submuscular transposition may be better for more severe cases. ^{1 2 3 4 5}

Is surgery for ulnar nerve entrapment generally safe?

Research shows that surgeries like simple decompression and anterior transposition for ulnar nerve entrapment are generally safe, with improvements in nerve function observed after surgery. These techniques have been studied in many patients and are considered effective and safe for treating this condition. ^{1 2 3 4 5}

How does the treatment for ulnar nerve entrapment differ from other treatments?

The treatment for ulnar nerve entrapment, which includes simple decompression and subcutaneous anterior transposition, is unique because it can be performed using minimally invasive techniques, such as endoscopic decompression, which may offer similar effectiveness to more invasive methods. Additionally, for mild cases (grade I), subcutaneous transposition is recommended, while more severe cases (grades II and III) may benefit more from modified submuscular transposition. ^{1 2 6 7 8}

Research Team

Kevin Chung, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic decompression of the ulnar nerve at the elbow. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Comparative study of different surgical transposition methods for ulnar nerve entrapment at the elbow. [2017]

3. Brazil pubmed.ncbi.nlm.nih.gov

ELBOW ULNAR NEUROPATHY: TREATMENT BY ANTERIOR TRANSPOSITION OF THE ULNAR NERVE. [2020]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Factors Influencing Outcomes after Ulnar Nerve Stability-Based Surgery for Cubital Tunnel Syndrome: A Prospective Cohort Study. [2022]

5. United States 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. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Surgical treatment for ulnar nerve entrapment at the elbow. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Submuscular versus subcutaneous anterior ulnar nerve transposition: a rat histologic study. [2009]