Evaluation of a nerve protector in surgery for cubital tunnel syndrome

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

This study is testing if a new nerve protector can help people with recurring ulnar nerve problems feel better and recover more effectively after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Axogen Corporation (Industry-sponsored)
• Locations: 7 sites (Tampa, Florida and 6 other locations)
• Trial ID: NCT06117501 on ClinicalTrials.gov

What this trial studies

This prospective case series aims to evaluate the effectiveness of Axoguard HA+ Nerve Protector™ in protecting the ulnar nerve during first revision cubital tunnel decompression surgery. Participants aged 18 and older with recurrent symptoms of ulnar nerve neuropathy will undergo surgery, and data will be collected on pain levels, functional outcomes, and quality of life before and after the procedure. The study will also assess the safety of the nerve protector and its potential to prevent future nerve compression issues. By analyzing these outcomes, the study seeks to establish the clinical benefits of using this device in surgical interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent ulnar nerve neuropathy symptoms following a primary decompression surgery.

Not a fit: Patients who have not undergone a primary cubital tunnel decompression or those with less severe symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and quality of life for patients undergoing revision surgery for cubital tunnel syndrome.

How similar studies have performed: While the use of nerve protectors in surgical procedures is gaining interest, this specific application in revision cubital tunnel surgery is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Be ≥ 18 years of age;
2. Have symptoms of ulnar nerve neuropathy near the elbow present at 180 days or greater following a primary cubital tunnel decompression procedure.
3. Be eligible for surgical intervention;
4. Have a preoperative diagnostic such as a nerve conduction study, electromyography, or ultrasound evaluation documenting ulnar neuropathy at the elbow;
5. Have a baseline pain visual analogue scale (VAS) score due to ulnar nerve neuropathy of no less than 40/100 mm for the affected elbow;
6. Have at least one of the following:

   * Paresthesia or numbness in the ulnar nerve distribution;
   * Weakness or wasting of the small muscles of the hand (full hand muscle wasting is excluded);
   * A positive elbow flexion provocation test.
7. Undergo a first revision cubital tunnel decompression surgery with placement of Axoguard HA+ Nerve Protector circumferentially around the section of ulnar nerve affected by neuropathy;
8. Be willing and able to comply with all aspects of the treatment and evaluation schedule over 18 months; and
9. Sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

1. Have had a previous revision cubital tunnel decompression procedure;
2. Have documented evidence of concomitant neuropathic conditions affecting the subject arm or any proximal condition affecting the subject arm including, but not limited to:

   * Previously treated carpal tunnel syndrome with unresolved symptoms or current carpal tunnel syndrome that will not be treated concurrently with the revision cubital tunnel;
   * Cervical or brachial plexus abnormalities or injuries;
   * Cervical spine or shoulder disease;
   * Thoracic outlet syndrome;
   * Complex regional pain syndrome;
   * Polyneuropathy, systemic neuropathy or Lyme disease related neuropathy;
   * Previous or current surgery of the ulnar nerve at the wrist (Guyon's canal release)
   * Ulnar nerve compression at the wrist/Guyon's canal;
3. Have current trauma or past trauma with ongoing pathology that interferes with evaluation or treatment of the ulnar nerve to either side shoulder or upper extremity;
4. Have previous radiofrequency ablation, presence of nerve stimulator or received nerve implant(s) in the subject arm or be receiving an implant(s) other than Axoguard HA+ Nerve Protector during the study surgical procedure, that will impact the ulnar nerve or planned study evaluations;
5. Have a condition(s) that could confound assessments or health-related quality of life including, but not limited to:

   * Rheumatoid arthritis
   * Fibromyalgia
   * Connective tissue disorder
   * Wrist tenosynovitis
6. Be a smoker or tobacco user;
7. Currently have or have a history of alcohol or drug abuse;
8. Have uncontrolled Diabetes Mellitus at the discretion of the treating surgeon or have diabetic neuropathy in the upper extremities;
9. Have documented poorly controlled hyperthyroidism or hypothyroidism;
10. Have a known sensitivity to porcine derived materials or those containing hyaluronate or alginate or their components;
11. Be currently taking or likely to need medication(s) that may cause or contribute to peripheral neuropathy or peripheral nerve dysfunction at the discretion of the treating surgeon;
12. Be taking prescribed medication(s) including, but not limited to, narcotics 2 or more times per week for the treatment of chronic pain or chronic nerve related symptoms NOT associated with the subject ulnar nerve neuropathy; or
13. Be deemed unsuitable for inclusion in the study at the discretion of the investigator.

Where this trial is running

Tampa, Florida and 6 other locations

• Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute) — Tampa, Florida, United States (Recruiting)
• Optim Orthopedics — Savannah, Georgia, United States (Recruiting)
• Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States (Recruiting)
• University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Rothman Orthopaedics — Philadelphia, Pennsylvania, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Stacy Arnold

Conditions Recurrent Cubital Tunnel Syndrome; Recalcitrant Cubital Tunnel Syndrome; Cubital Tunnel Syndrome; Revision Cubital Tunnel Surgery; First Revision Cubital Tunnel Syndrome Decompression; Ulnar Nerve; Ulnar Nerve Neuropathy; Nerve Protection