ACTIVE_NOT_RECRUITING

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

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 Axoguard HA+ Nerve Protector

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

Quick Facts

Study Start:2023-10-19

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06117501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute)

Tampa, Florida, 33607

United States

Optim Orthopedics

Savannah, Georgia, 31405

United States

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260

United States

University of New Mexico

Albuquerque, New Mexico, 87131

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Rothman Orthopaedics

Philadelphia, Pennsylvania, 19107

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Axogen Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-19

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-10-19

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Recurrent Cubital Tunnel Syndrome
Recalcitrant Cubital Tunnel Syndrome