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Procedure

Axoguard Nerve Protector for Cubital Tunnel Syndrome (COVERED Trial)

N/A
Recruiting
Research Sponsored by Axogen Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be eligible for surgical intervention;
Have a preoperative diagnostic such as a nerve conduction study, electromyography, or ultrasound evaluation documenting ulnar neuropathy at the elbow;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how well Axoguard HA+ Nerve Protector can protect a nerve during a cubital tunnel operation. It'll measure pain, motor/sensory outcomes, QoL, & more to see if it's successful.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications such as infection, bleeding, or adverse reactions to the implant material used to protect the nerve.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for surgery.
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I have had a test confirming elbow nerve damage.
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I have weakness or muscle loss in my hand.
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I am having my first surgery to fix cubital tunnel syndrome with a specific nerve protector.
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I feel numbness or tingling in my pinky and ring fingers.
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My elbow pain from ulnar nerve issues scores at least 40 out of 100.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual analog scale (VAS)
Secondary study objectives
12-Item Short Form Health Survey (SF-12)
Grip strength
Modified McGowan classification
+5 more
Other study objectives
Proportion of participants with healthy ulnar nerve appearance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: First Revision Cubital Tunnel with application of Axoguard HA+ Nerve ProtectorExperimental Treatment1 Intervention
Single group assignment. Patients will receive the Axoguard HA+ Nerve Protector™ in their first revision cubital tunnel surgery.

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Who is running the clinical trial?

Axogen CorporationLead Sponsor
10 Previous Clinical Trials
5,568 Total Patients Enrolled
~13 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
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