Axoguard Nerve Protector for Cubital Tunnel Syndrome

(COVERED Trial)

Not currently recruiting at 6 trial locations

Overseen By Hayley Nicolosi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Axogen Corporation

Must not be taking: Narcotics, others

Disqualifiers: Carpal tunnel, Polyneuropathy, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Axoguard HA+ Nerve Protector™, a device used during surgery to protect the ulnar nerve in individuals experiencing issues after previous cubital tunnel surgery. The focus is on improving symptoms such as pain, numbness, or muscle weakness due to cubital tunnel syndrome, which affects the nerve near the elbow. Individuals with ongoing symptoms for at least six months after their first cubital tunnel surgery and planning a second surgery might be suitable for this study. The trial will track changes in pain, movement, and overall quality of life over time. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially improve health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that may cause or contribute to nerve problems, or if you are using narcotics frequently for pain not related to your ulnar nerve, you might need to stop or adjust them. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Axoguard HA+ Nerve Protector is safe for use in cubital tunnel decompression procedures?

Research has shown that the Axoguard HA+ Nerve Protector is safe for use in surgeries. In a study with 71 patients, researchers found no safety issues. All patients improved without negative side effects. The FDA has approved this device, indicating it meets specific safety standards. While individual results may vary, evidence suggests the treatment is generally safe and well-tolerated for those undergoing cubital tunnel decompression surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical approaches for cubital tunnel syndrome, which often involve nerve transposition or decompression, the Axoguard HA+ Nerve Protector introduces a unique protective barrier to support nerve healing. This treatment is exciting because it uses a specialized hydrogel that acts as a cushion, potentially reducing scar tissue formation and improving nerve regeneration. Researchers are hopeful that this novel approach will offer better outcomes by enhancing the natural healing process and reducing the risk of complications compared to traditional methods.

What evidence suggests that the Axoguard HA+ Nerve Protector is effective for cubital tunnel syndrome?

Research shows that the Axoguard HA+ Nerve Protector could help treat cubital tunnel syndrome. In studies, this nerve protector has shown promise for patients with persistent symptoms like pain and numbness after previous surgeries. It acts as a shield around the nerve, reducing irritation and aiding healing. Early results suggest it is safe and effective, forming a protective layer similar to natural nerve tissue. This method has improved outcomes for patients with recurring symptoms post-surgery. Participants in this trial will receive the Axoguard HA+ Nerve Protector during their first revision cubital tunnel surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had previous cubital tunnel decompression surgery but still experience symptoms like pain, numbness, or muscle weakness in the hand. They must have documented ulnar nerve issues at the elbow and be ready for a first revision surgery where Axoguard HA+ Nerve Protector will be used.

Inclusion Criteria

You have pain or discomfort when your elbow is bent.

I am eligible for surgery.

I have had a test confirming elbow nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Baseline

Baseline assessments including demographics, primary decompression details, and health-related QoL questionnaires

1 day

1 visit (in-person)

Operative Day

Application of Axoguard HA+ Nerve Protector during first revision cubital tunnel surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including pain assessment and functional outcomes

18 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Axoguard HA+ Nerve Protector™

Trial Overview The study is testing Axoguard HA+ Nerve Protector's effectiveness in protecting the ulnar nerve during a first revision of cubital tunnel decompression surgery. It aims to assess pain relief, motor and sensory function improvement, quality of life enhancement, and whether it prevents further surgeries.

How Is the Trial Designed?

Group I: First Revision Cubital Tunnel with application of Axoguard HA+ Nerve Protector Experimental Treatment 1 Intervention

Single group assignment. Patients will receive the Axoguard HA+ Nerve Protector™ in their first revision cubital tunnel surgery.

Axoguard HA+ Nerve Protector™ is already approved in United States, European Union for the following indications:

Approved in United States as Axoguard HA+ Nerve Protector for:

• Management and protection of peripheral nerve injuries where there is no gap, or following closure of the gap.

Approved in European Union as Axoguard HA+ Nerve Protector for:

• Management of peripheral nerve injuries where there is no gap.

Who Is Running the Clinical Trial?

Axogen Corporation

Lead Sponsor

Trials

11

Recruited

5,600+

Published Research Related to This Trial

In a study of 34 patients undergoing cubital tunnel decompression, there was no significant difference in early and medium-term outcomes between those who received local anesthesia (LA) and those who received general anesthesia (GA), as measured by the PRUNE score.

The findings suggest that using local anesthesia for this procedure can reduce anesthetic risks and lower costs without compromising patient outcomes, making it a favorable option for cubital tunnel decompression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cubital Tunnel Decompression: Equivalent Outcome Scores when Procedure Performed with Local versus General Anesthetic. Ajwani, SH., Unsworth, RM., Tseng, M., et al.[2020]

AxoGuard nerve wrap, used in conjunction with neurolysis and tenosynovectomy, has previously shown no safety concerns in treating recurrent carpal and ulnar tunnel syndrome, but a case of necrotic granulomatous inflammation was reported 2.5 months after its application.

As a salvage treatment, a NuShield placental allograft was successfully used around the median nerve, indicating that placental allografts may be effective for patients with compression neuropathy who do not respond to other surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necrotic Granulomatous Inflammation after Use of Small Intestine Submucosa Matrix for Recurrent Compression Neuropathy. Koenig, ZA., Burns, JC., Hayes, JD.[2022]

In a study of 12 patients with recurrent cubital tunnel syndrome, revision surgery combined with porcine extracellular matrix nerve wrapping led to significant improvements in pain levels, grip strength, and pinch strength after an average follow-up of 41 months.

The use of porcine extracellular matrix for nerve wrapping was found to be safe, with no complications reported, indicating its potential as an effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of recurrent cubital tunnel syndrome treated with neurolysis and porcine extracellular matrix nerve wrap. Papatheodorou, LK., Williams, BG., Sotereanos, DG.[2015]

Cubital tunnel syndrome (CuTS) is a common condition caused by compression of the ulnar nerve, and its diagnosis can be confirmed through nerve conduction studies, ultrasound, or MRI, which reveal changes in the nerve's structure.

For treatment, conservative methods like splinting are effective in early stages, but if symptoms worsen, surgical options such as in situ decompression are recommended, with studies showing this method is effective for primary cases and certain secondary forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cubital tunnel syndrome - a review and management guidelines. Assmus, H., Antoniadis, G., Bischoff, C., et al.[2022]

Cubital tunnel syndrome is the most common type of ulnar nerve entrapment, making it a significant concern in upper extremity neuropathies, second only to carpal tunnel syndrome.

Bilateral compressive ulnar neuropathy is rare, but electrodiagnostic studies are effective tools for accurately diagnosing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual presentation of multiple nerve entrapment: a case report. Citisli, V., Kocaoglu, M., Göcmen, S., et al.[2018]

The study evaluated 20 patients who underwent revision surgeries for recurrent compressive neuropathies in the upper extremity, using the VersaWrap nerve protector, and found it to be safe and effective with no need for further revision surgeries.

All patients reported subjective improvement in symptoms postoperatively, with a mean DASH score of 57.7 and a VAS score of 3.1, indicating significant satisfaction with the surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes following use of VersaWrap nerve protector in treatment of patients with recurrent compressive neuropathies. Hones, KM., Nichols, DS., Barker, H., et al.[2023]

In a study of 70 patients with mild to moderate cubital tunnel syndrome, 89.5% showed improvement after six months, indicating a generally good prognosis for conservative treatment.

There were no significant differences in outcomes between treatment groups (night splinting, nerve gliding, and control), suggesting that these specific interventions may not provide additional benefits beyond patient education on symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment of the cubital tunnel syndrome. Svernlöv, B., Larsson, M., Rehn, K., et al.[2011]

Cubital tunnel syndrome, a common nerve compression issue, is best diagnosed through clinical examination and nerve conduction studies, with neurosonography and MRI providing valuable insights into morphological changes.

For treatment, simple in situ decompression of the ulnar nerve is the most effective approach for the primary form of the syndrome, while more complex cases may require nerve transposition, though this carries risks such as impaired blood flow and nerve kinking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis and therapy of cubital tunnel syndrome--state of the art]. Assmus, H., Antoniadis, G., Bischoff, C., et al.[2009]

A limited surgical decompression of the ulnar nerve in the cubital tunnel was effective in relieving pain and discomfort in 22 out of 27 patients, indicating a high efficacy of this procedure.

No patients experienced muscle weakness or atrophy before surgery, and most showed signs of nerve compression, suggesting that the surgery addresses a common issue without pre-existing muscle damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulnar nerve decompression at the cubital tunnel. Manske, PR., Johnston, R., Pruitt, DL., et al.[2005]

Cubital tunnel syndrome is a specific type of ulnar neuropathy caused by nerve entrapment at the elbow, affecting 9 patients in this study, with 6 experiencing it bilaterally.

Electrophysiological tests showed abnormal nerve conduction in 9 out of 15 ulnar nerves, confirming that a tight band compressing the ulnar nerve at the cubital tunnel is responsible for the symptoms, which was also observed during surgery in 7 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cubital tunnel syndrome: diagnosis and precise localization. Miller, RG.[2004]

Citations

1. withpower.com withpower.com/trial/phase-cubital-tunnel-syndrome-9-2023-c95f4

Axoguard Nerve Protector for Cubital Tunnel Syndrome This trial is for adults over 18 who've had previous cubital tunnel decompression surgery but still experience symptoms like pain, numbness, or muscle weakness ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06117501/nerve-protection-evaluation-revision-cubital-tunnel-syndrome-decompression

Nerve Protection Evaluation: Revision Cubital Tunnel ... To evaluate the use and characterize the performance of Axoguard HA+ Nerve Protector to protect the ulnar nerve in a first revision cubital ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12111848/

Peripheral Nerve Protection Strategies: Recent Advances and ... This review highlights the latest developments in nerve wraps, their clinical applications, limitations, and future potential

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25911210/

Preliminary results of recurrent cubital tunnel syndrome ... This study found that secondary decompression combined with porcine extracellular matrix nerve wrapping was an effective and safe treatment for patients with ...

5. axogeninc.com axogeninc.com/hcp/procedure/nerve-decompression/

nerve decompression procedures Axoguard Nerve Protector® remodels into a protective layer, similar to nerve epineurium, in 6 months.7; In a series of 12 patients with recurrent cubital tunnel ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22107412&pc=JXI

MAUDE Adverse Event Report: AXOGEN CORPORATION ... The patient underwent a the second revision of the cubital tunnel release, which was the third operation performed on (b)(6) 2024, which involved the ...

7. axogeninc.com axogeninc.com/wp-content/uploads/2025/05/MAT-US-AXHA-0002-Axoguard-HA-Product-Flyer-5.15.25.pdf

axoguard HA+ nerve protector™ is the first SIS, ... Preliminary results of recurrent cubital tunnel syndrome treated with neurolysis and porcine extracellular matrix nerve wrap. Journal of Hand Surgery, 40(5) ...