Recurrent Cubital Tunnel SyndromeCOVEREDNCT06117501

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

A study testing Axoguard HA+ Nerve Protector™ in people with Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome, run by Axogen Corporation at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
What is being tested?: Axoguard HA+ Nerve Protector™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 7 sitesUnited States
Study dates: 19 Oct 2023to 17 Aug 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 12Show fewer

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.

Who cannot join

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;

Show all 25Show fewer

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Cleveland Clinic
Cleveland, Ohio, 44195
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Rothman Orthopaedics
Philadelphia, Pennsylvania, 19107
University of Utah
Salt Lake City, Utah, 84132
Optim Orthopedics
Savannah, Georgia, 31405
Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute)
Tampa, Florida, 33607

Other trials in United States

About this study

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.

Read the detailed description

The objectives of this study are:

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 by understanding post-operative outcomes (pain level, QoL, PROMs, and ulnar nerve specific functional outcomes) compared to baseline (pre-revision operative levels).
To summarize the safety of Axoguard HA+ Nerve Protector, an FDA-cleared device, in first revision cubital tunnel decompression procedures.
To characterize the feasibility of Axoguard HA+ Nerve Protector to prevent the recurrence of compressive neuropathy of the ulnar nerve at the elbow and resulting need for future revision procedures.
To characterize the feasibility of imaging the ulnar nerve pre- and post-operatively to assess nerve and tissue bed health.

The study population includes participants 18 years of age or older presenting for evaluation of surgery for compressive ulnar nerve neuropathy at the elbow following a primary cubital tunnel syndrome decompression.

Data will be collected from available medical records and patient reported outcomes questionnaires using approved data collection forms (paper or electronic). The following data will be collected at the respective study visits: demographics, primary decompression details, revision decompression details, baseline assessments, health-related QoL questionnaires, functional assessments, and recovery assessments.

There will be a total of nine (9) study visits (Pre-op Screening/Baseline and Operative Day visits plus seven (7) study follow-up events).

Conditions: Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
Being tested: Axoguard HA+ Nerve Protector™
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
Medical subject headings: Cubital Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06117501
Study group	Role	What they receive
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. Receives: Device: Axoguard HA+ Nerve Protector™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6-18 months

Secondary outcomes (8)

Visual Analog Scale (VAS)
Pain will be assessed on each study visit using a 100 mm visual analog scale (VAS).
Measured: 3 months
Grip strength
Grip strength will be measured for both arms using a hand dynamometer.
Measured: 18 months
Semmes-Weinstein Monofilament test
Semmes-Weinstein Monofilament test will be performed to assess sensibility by evaluating the tactile sensitivity to pressure in both hands to pressure applied by the monofilaments.
Measured: 18 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
QuickDASH is a patient-reported outcome questionnaire to measure physical functions and symptoms in patients with upper limb musculoskeletal disorders including cubital tunnel syndrome. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5).
Measured: 18 months
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Bank v2.1 Upper Extremity
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Bank v2.1 - Upper Extremity is a patient questionnaire developed to assess upper extremity physical function in patients with hand and upper extremity conditions as a separate domain from general physical function.
Measured: 18 months
Patient-Rated Ulnar Nerve Evaluation (PRUNE)
The Patient-Rated Ulnar Nerve Evaluation (PRUNE) score is a brief, open-access, patient-reported outcome measure specifically for patients with ulnar nerve compression at the elbow that assesses pain, symptoms and functional disability.
Measured: 18 months
Modified McGowan classification
McGowan classification grades the severity of CuTS based on patient-reported symptoms and physical examination findings.
Measured: 18 months
12-Item Short Form Health Survey (SF-12)
The 12-Item Short Form Health Survey (SF-12) is a self-reported, health-related quality of life questionnaire assessing the impact of health on an individual's everyday life.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202317 Aug 2026

First posted7 Nov 2023
Study start19 Oct 2023
Primary completion17 Aug 2026
Study completion17 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurrent Cubital Tunnel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06117501
Sponsor's protocol ID: ANP-CP-001
Acronym: COVERED
Status last verified: Oct 2026
First submitted: 27 Oct 2023
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
ClinicalTrials.gov ID: NCT06117501
Acronym / sponsor ID: COVERED / ANP-CP-001
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Axogen CorporationIndustry (pharma, biotech, devices)
Study start: 19 Oct 2023 (actual)
Primary completion: 17 Aug 2026 (actual)
Study completion: 17 Aug 2026 (actual)
First posted: 7 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The objectives of this study are:

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 by understanding post-operative outcomes (pain level, QoL, PROMs, and ulnar nerve specific functional outcomes) compared to baseline (pre-revision operative levels).
To summarize the safety of Axoguard HA+ Nerve Protector, an FDA-cleared device, in first revision cubital tunnel decompression procedures.
To characterize the feasibility of Axoguard HA+ Nerve Protector to prevent the recurrence of compressive neuropathy of the ulnar nerve at the elbow and resulting need for future revision procedures.
To characterize the feasibility of imaging the ulnar nerve pre- and post-operatively to assess nerve and tissue bed health.

There will be a total of nine (9) study visits (Pre-op Screening/Baseline and Operative Day visits plus seven (7) study follow-up events).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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;

Key exclusion criteria (25 listed)

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:
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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	First Revision Cubital Tunnel with application of Axoguard HA+ Nerve Protector

Primary outcome

Visual analog scale (VAS)
Time frame: 6-18 months
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.

8 secondary outcomes

Visual Analog Scale (VAS)
Time frame: 3 months
Grip strength
Time frame: 18 months
Semmes-Weinstein Monofilament test
Time frame: 18 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Time frame: 18 months
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Bank v2.1 Upper Extremity
Time frame: 18 months
Patient-Rated Ulnar Nerve Evaluation (PRUNE)
Time frame: 18 months
Modified McGowan classification
Time frame: 18 months
12-Item Short Form Health Survey (SF-12)
Time frame: 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Axoguard HA+ Nerve Protector™ in people with Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome, run by Axogen Corporation at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale (VAS) (time frame: 6-18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06117501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.