Axoguard Nerve Protector for Cubital Tunnel Syndrome

(COVERED Trial)

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression utilizing Axoguard HA+ Nerve Protector, participant-reported pain, motor and sensory functional outcomes, quality of life (QoL) outcomes, and recurrence/revision will be collected. This case series will help to establish the ability of Axoguard HA+ Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure.

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 data supports the effectiveness of the treatment Axoguard HA+ Nerve Protector for cubital tunnel syndrome?

Research shows that using AxoGuard nerve wrap, which is similar to Axoguard HA+ Nerve Protector, has been promising in treating compression neuropathies like cubital tunnel syndrome, with no safety concerns reported. It has been effective when used with other surgical techniques to relieve symptoms. ^{1 2 3 4 5}

Is Axoguard Nerve Protector safe for use in humans?

Research indicates that Axoguard Nerve Protector has shown no safety concerns in previous studies, with no reported cases of infection, persistent inflammation, or recurrent issues. However, there was a case of inflammation reported after its use, suggesting that while generally safe, there may be rare adverse reactions. ^{1 2 3 6 7}

How does the Axoguard HA+ Nerve Protector treatment differ from other treatments for cubital tunnel syndrome?

The Axoguard HA+ Nerve Protector is unique because it acts as a protective barrier around the nerve, potentially reducing scar tissue formation and promoting healing, which is different from traditional surgical methods that focus on decompressing or repositioning the nerve. ^{3 4 8 9 10}

Eligibility Criteria

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.

You are able to follow the treatment and check-up schedule for at least 18 months.

I am eligible for surgery.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

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

Preliminary results of recurrent cubital tunnel syndrome treated with neurolysis and porcine extracellular matrix nerve wrap. [2015]

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

Necrotic Granulomatous Inflammation after Use of Small Intestine Submucosa Matrix for Recurrent Compression Neuropathy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Conservative treatment of the cubital tunnel syndrome. [2011]

4. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis and therapy of cubital tunnel syndrome--state of the art]. [2009]

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

Ulnar nerve decompression at the cubital tunnel. [2005]

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

Cubital Tunnel Decompression: Equivalent Outcome Scores when Procedure Performed with Local versus General Anesthetic. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes following use of VersaWrap nerve protector in treatment of patients with recurrent compressive neuropathies. [2023]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Cubital tunnel syndrome - a review and management guidelines. [2022]

10. Uganda pubmed.ncbi.nlm.nih.gov

Unusual presentation of multiple nerve entrapment: a case report. [2018]