Status:
ACTIVE_NOT_RECRUITING
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
Lead Sponsor:
Axogen Corporation
Conditions:
Recurrent Cubital Tunnel Syndrome
Recalcitrant Cubital Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 decompressio...
Detailed Description
The objectives of this study are: 1. To evaluate the use and characterize the performance of Axoguard HA+ Nerve Protector to protect the ulnar nerve in a first revision cubital tunnel decompression b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Connective tissue disorder
- Wrist tenosynovitis
- Be a smoker or tobacco user;
- Currently have or have a history of alcohol or drug abuse;
- Have uncontrolled Diabetes Mellitus at the discretion of the treating surgeon or have diabetic neuropathy in the upper extremities;
- Have documented poorly controlled hyperthyroidism or hypothyroidism;
- Have a known sensitivity to porcine derived materials or those containing hyaluronate or alginate or their components;
- 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;
- 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
- Be deemed unsuitable for inclusion in the study at the discretion of the investigator.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06117501
Start Date
October 19 2023
End Date
December 1 2026
Last Update
October 7 2025
Active Locations (7)
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1
Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute)
Tampa, Florida, United States, 33607
2
Optim Orthopedics
Savannah, Georgia, United States, 31405
3
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131