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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06117501




Registration number
NCT06117501
Ethics application status
Date submitted
27/10/2023
Date registered
7/11/2023

Titles & IDs
Public title
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
Scientific title
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
Secondary ID [1] 0 0
ANP-CP-001
Universal Trial Number (UTN)
Trial acronym
COVERED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Cubital Tunnel Syndrome 0 0
Recalcitrant Cubital Tunnel Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Axoguard HA+ Nerve Protector™

Other: First Revision Cubital Tunnel with application of Axoguard HA+ Nerve Protector - Single group assignment. Patients will receive the Axoguard HA+ Nerve Protector™ in their first revision cubital tunnel surgery.


Treatment: Devices: Axoguard HA+ Nerve Protector™
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analog scale (VAS)
Timepoint [1] 0 0
6-18 months
Secondary outcome [1] 0 0
Visual Analog Scale (VAS)
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Grip strength
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Semmes-Weinstein Monofilament test
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Bank v2.1 Upper Extremity
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
Patient-Rated Ulnar Nerve Evaluation (PRUNE)
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Modified McGowan classification
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
12-Item Short Form Health Survey (SF-12)
Timepoint [8] 0 0
18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New Mexico
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Axogen Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stacy Arnold
Address 0 0
Country 0 0
Phone 0 0
386-462-6900
Fax 0 0
Email 0 0
clinicalresearch@axogeninc.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06117501