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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

Clinicaltrials.gov identifier NCT03940963

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted August 10, 2020

Study Description

Brief summary:

Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot. Study consists of a 15 subject pilot phase with Axoguard Nerve Cap implants followed for 3 months and then a comparative study of 86 subjects randomized between the treatment groups followed for 12 months.

  • Condition or Disease:Morton's Neuroma
    Chronic Nerve Pain
    Symptomatic Neuroma
  • Intervention/Treatment: Device: AxoGuard® Nerve Cap
    Procedure: Standard Neurectomy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 101 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multicenter, Prospective, Randomized and Subject Blinded Comparative Study of AxoGuard® Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: November 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: AxoGuard® Nerve Cap
Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of AxoGuard® Nerve Cap at the time of surgery
Device: AxoGuard® Nerve Cap
Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
Active Comparator: Standard Neurectomy
Standard surgical treatment for symptomatic neuroma entailing neuroma excision.
Procedure: Standard Neurectomy
Surgical excision of symptomatic neuroma
Outcome Measures
  • Primary Outcome Measures: 1. Change in Visual Analog Scale (VAS) For Pain Score at 3 post-operative months in Pilot Phase Subjects [ Time Frame: 3 months ]
    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".
  • 2. Change in Visual Analog Scale (VAS) For Pain Score at 12 post-operative months in Comparative Phase Subjects. [ Time Frame: 12 months ]
    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".
  • 3. Safety: Serious Adverse Events (SAEs) [ Time Frame: 3 months ]
    The primary safety endpoint will compare the nature and incidence of SAEs between treatment groups
  • 4. Safety: Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 3 months ]
    The primary safety endpoint will compare the nature and incidence of AEs between treatment groups
  • Secondary Outcome Measures: 1. Changes in Visual Analog Scale (VAS) For Pain score through 12 post-operative months compared to baseline. [ Time Frame: 1, 3, 6, 9, and 12 months ]
    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".
  • 2. 2. Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through 12 post-operative months compared to baseline. [ Time Frame: Time Frame: 1, 3, 6, 9 and 12 months ]
    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 PROMIS - pain related measures include domains evaluating fatigue, pain intensity, paint 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 measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac_scoringservice).
  • 3. Change in Foot Health Status Questionnaire (FHSQ) Score at 1,3,6,9, and 12 post-operative months compared to baseline. [ Time Frame: Time Frame: 1, 3, 6, 9 and 12 months ]
    The Foot Health Status Questionnaire (FHSQ) measures foot health related to quality of life based on responsiveness in overall foot health status in 4 subscale areas (foot function, foot health, footwear and foot pain). The FHSQ is comprised of 13 questions. The questionnaire is self-administered. Subscale ratings are summed and the FHSQ score is reported as 0 (representing poorest state of foot health) to 100 (representing optimal foot health) with higher scores reflecting better foot health and quality of life.
  • 4. Changes in quantity, quality and class of pain medication use at 1,3,6,9 and 12 months comparted to baseline. [ Time Frame: Time Frame: 1, 3, 6, 9 and 12 months ]
    Subjects will maintain a daily pain medication and concomitant medication diary which logs the quantity, quality, and class of pain medication administered and taken at 1,3,6,9 and 12 post-operative months.
  • 5. SAEs, AEs, and/or UADEs [ Time Frame: 6, 9, and 12 months ]
    The secondary safety endpoint will compare the nature and incidence of SAEs, AEs, and UADEs between treatment groups
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria (Potential Subjects must):

1. Be able and willing to provide documented informed consent prior to the conduct of any
study procedures;

2. Be an adult male or non-pregnant female ≥ 18 years of age;

3. Report baseline pain scores of >65mm on a 100mm Visual Analog Scale (VAS) at
screening;

4. Have a documented diagnosis of symptomatic neuroma in at least one nerve in the foot
or ankle up to 10 mm proximal to the lateral malleolus, which cannot be repaired to a
distal nerve end and which is confirmed by the following diagnostic criteria for
symptomatic neuroma;

Must have all 3 of the of the following:

- Pain with at least 3 of the following characteristics: burning, sharp, shooting,
electric, parasthesias, numbness, cold intolerance;

- Symptoms in a defined neural anatomic distribution

- History of nerve injury or suspected nerve injury

Must have at least 1:

- Positive response to local anesthetic injection

- US or MRI confirmation of neuroma

5. Be candidates indicated for surgery to address a symptomatic neuroma;

6. Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve
Cap;

7. In the surgeon's opinion, be likely to achieve complete resection of the symptomatic
neuroma and be able to undergo implantation with the Axoguard® Nerve Cap or complete
the neurotomy procedure in the control group;

8. Be willing and able to comply with all aspects of the treatment and evaluation
schedule over a 12-month duration.

Exclusion Criteria (Potential Subjects must not):

1. Have undergone surgical treatment of pain from symptomatic neuroma in the target
nerve(s)on three or more occasions;

2. Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis,
sesamoid bone pain, tendinitis, etc);

3. Have a life expectancy of less than 12 months;

4. Have a history of or planned radiotherapy in the area of the end-neuroma;

5. Be contraindicated for soft tissue implants.; this includes but is not limited to any
pathology that would limit the blood supply; compromise healing or indicate the
presence of a local infection;

6. Have a history of chronic ischemic conditions of the extremity;

7. Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus
(at the discretion of the investigator);

8. Have a history of diabetic neuropathy;

9. Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy,
or other known treatment which affects the growth of neural and/or vascular system;

10. Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy
within 12 months following the study procedure;

11. Have a History of congenital neuropathy or compressive neuropathy affecting the target
limb;

12. Have a history of prior surgical management of more proximal compressive neuropathies
not related to the symptomatic neuroma that affect the target limb;

13. Currently use or likely need to use medication during the study known to impact nerve
regeneration or to cause peripheral neuropathy;

14. Be pregnant or plan to become pregnant during the duration of the study;

15. Be or have been enrolled in another interventional study within 30 days prior to
consenting;

16. Have a known allergy to anesthetic agents;

17. Have a known sensitivity to porcine derived materials; or

18. Be, in the opinion of the Investigator, unsuitable for inclusion in the study.

Contacts and Locations
Contacts

Contact: Stacy Arnold 386-462-6800 clinicalresearch@axogeninc.com

Locations

United States, Florida
Anastasia Medical Group
Saint Augustine

United States, Illinois
OrthoIllinois
Rockford

United States, Ohio
Foot and Ankle Specialists of Ohio
Mentor

United States, Pennsylvania
Premier Foot & Ankle Specialists
York

United States, Texas
Austin Foot and Ankle Specialists
Austin

United States, Texas
Complete Foot and Ankle Care of North Texas
Denton

United States, Texas
JPS Health Network
Fort Worth

United States, Utah
Foot & Ankle Institute
Saint George

United States, Utah
Wasatch Clinical Research
Salt Lake City

United States, Wisconsin
Comprehensive Orthopaedics, S.C.
Kenosha

Sponsors and Collaborators

Axogen Corporation

More Information
  • Responsible Party: Axogen Corporation
  • ClinicalTrials.gov Identifier: NCT03940963 History of Changes
  • Other Study ID Numbers: CAP-CP-001
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: August 10, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Axogen Corporation: Nerve Repair
    Surgical Treatment of Pain
    Peripheral Nerve Injuries
    Peripheral Nervous System Disease
    Foot Neuroma
    Foot Pain
    Wounds and Injuries
    Nerve Foot Pain
    Nervous System Diseases
    Trauma - Nervous System
  • Additional relevant MeSH terms: Neuroma
    Morton Neuroma
    Neuralgia