Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

NCT06117501 | Active Not Recruiting FDA Device

• 1 other identifier: ANP-CP-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Recurrent Cubital Tunnel Syndrome; Recalcitrant Cubital Tunnel Syndrome

Keywords

Cubital Tunnel Syndrome; Revision Cubital Tunnel Surgery; First Revision Cubital Tunnel Syndrome Decompression; Ulnar Nerve; Ulnar Nerve Neuropathy; Nerve Protection; Axoguard HA+ Nerve Protector

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  Change from baseline in visual analog scale (VAS) pain scores (0-100 mm) will be evaluated between post-operative months 6 to 18 to characterize treatment response over time.

  6-18 months

Secondary Outcomes (8)

• Visual Analog Scale (VAS)

  3 months

• Grip strength

  18 months

• Semmes-Weinstein Monofilament test

  18 months

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score

  18 months

• Patient-Reported Outcomes Measurement Information System® (PROMIS®) Bank v2.1 Upper Extremity

  18 months

Other Outcomes (1)

• Proportion of participants with healthy ulnar nerve appearance

  18 months

Study Arms (1)

First Revision Cubital Tunnel with application of Axoguard HA+ Nerve Protector

OTHER

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

Device: Axoguard HA+ Nerve Protector™

Interventions

Axoguard HA+ Nerve Protector™ DEVICE

Axoguard HA+ Nerve Protector™ is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries where there is no gap. Axoguard HA+ Nerve Protector™ is designed to be an interface between the nerve and the surrounding tissue.

First Revision Cubital Tunnel with application of Axoguard HA+ Nerve Protector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 years of age;
• Have symptoms of ulnar nerve neuropathy near the elbow present at 180 days or greater following a primary cubital tunnel decompression procedure.
• 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;
• 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;
• 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.
• 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;
• Be willing and able to comply with all aspects of the treatment and evaluation schedule over 18 months; and
• Sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent prior to initiation of any study procedures.

You may not qualify if:

• Have had a previous revision cubital tunnel decompression procedure;
• 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;
• 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;
• 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;
• Have a condition(s) that could confound assessments or health-related quality of life including, but not limited to:
• Rheumatoid arthritis
• Fibromyalgia

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (7)

Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute)

Tampa, Florida, 33607, United States

Location

Optim Orthopedics

Savannah, Georgia, 31405, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rothman Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 7, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)