Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

N/AActive Not RecruitingNCT04865679

Axogen Corporation15 enrolled

Overview

This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Symptomatic Neuroma Amputation Chronic Nerve Pain

Interventions

Axoguard Nerve Cap®DEVICE

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Potential Subjects MUST: 1. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures; 2. Be an adult male or female ≥ 18 and ≤ 80 years of age; 3. Present for surgery with either: 1. Limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12 months from time of amputation, or; 2. A previous amputation and be undergoing surgery to address nerve ends; 4. Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump; 5. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap; 6. Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration. Exclusion Criteria: Potential Subjects MUST NOT: 1. Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues; 2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy; 3. Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study; 4. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection; 5. Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing; 6. Have a life expectancy of less than 15-months; 7. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma; 8. Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement; 9. Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site; 10. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain; 11. Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb; 12. Have a known allergy to anesthetic agents; 13. Have a known sensitivity to porcine-derived products; 14. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or 15. Be deemed unsuitable for inclusion in the study at the discretion of the investigator.

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Texas Tech University, Health Science Center

Lubbock, Texas, United States

Outcomes

Primary Outcomes

Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)

The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.

Time frame: 15 Months

Secondary Outcomes

Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline

The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable". Final VAS score will be collected either just prior to TMR or RPNI procedure or 12- months post op if subject will not undergo the secondary TMR or RPNI procedure

Time frame: Week 2, 1, 3, 6, 9 and 12 months

Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline

The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The pain related measures include domains evaluating fatigue, pain intensity, pain interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measured where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). Final PROMIS® Pain Related Measure will be collected either just prior to TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure.

Data from ClinicalTrials.gov

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