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

Primary Purpose

Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AxoGuard® Nerve Cap
Standard Neurectomy
Sponsored by
Axogen Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Neuroma focused on measuring Peripheral Nerve Injuries, Peripheral Nervous System Disease, Foot Neuroma, Foot Pain, Nerve Foot Pain, Nervous System Diseases, Trauma - Nervous System, Wounds and Injuries, Nerve Repair, Surgical Treatment of Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 of at least one interdigital nerve in the foot which cannot be repaired to a distal nerve end;
  5. Must have 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
  6. Be candidates indicated for surgery to address a symptomatic neuroma;
  7. Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap;
  8. 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;
  9. 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 or spinal conditions (e.g. spinal stenosis) 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.

Sites / Locations

  • New Hope Podiatry Group
  • Anastasia Medical Group
  • EHI Clinical Research
  • Gateway Clinical Trials
  • OrthoIllinois
  • Foot and Ankle Center of Illinois
  • The Ohio State University
  • Austin Foot and Ankle Specialists
  • Complete Foot and Ankle Care of North Texas
  • JPS Health Network
  • Foot & Ankle Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AxoGuard® Nerve Cap

Standard Neurectomy

Arm Description

Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of AxoGuard® Nerve Cap at the time of surgery

Standard surgical treatment for symptomatic neuroma entailing neuroma excision.

Outcomes

Primary Outcome Measures

Change in Visual Analog Scale (VAS) For Pain Score at 3 post-operative months in Pilot Phase Subjects
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".
Change in Visual Analog Scale (VAS) For Pain Score at 12 post-operative months in Comparative Phase Subjects.
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".
Safety: Serious Adverse Events (SAEs)
The primary safety endpoint will compare the nature and incidence of SAEs between treatment groups
Safety: Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs)
The primary safety endpoint will compare the nature and incidence of AEs between treatment groups

Secondary Outcome Measures

Changes in Visual Analog Scale (VAS) For Pain score through 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".
2. Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through 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 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).
Change in Foot Health Status Questionnaire (FHSQ) Score at 1,3,6,9, and 12 post-operative months compared to baseline.
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.
Changes in quantity, quality and class of pain medication use at 1,3,6,9 and 12 months comparted to baseline.
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.
SAEs, AEs, and/or UADEs
The secondary safety endpoint will compare the nature and incidence of SAEs, AEs, and UADEs between treatment groups

Full Information

First Posted
May 6, 2019
Last Updated
July 24, 2023
Sponsor
Axogen Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03940963
Brief Title
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
Acronym
REPOSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
July 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axogen Corporation

4. Oversight

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.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
Keywords
Peripheral Nerve Injuries, Peripheral Nervous System Disease, Foot Neuroma, Foot Pain, Nerve Foot Pain, Nervous System Diseases, Trauma - Nervous System, Wounds and Injuries, Nerve Repair, Surgical Treatment of Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AxoGuard® Nerve Cap
Arm Type
Active Comparator
Arm Description
Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of AxoGuard® Nerve Cap at the time of surgery
Arm Title
Standard Neurectomy
Arm Type
Active Comparator
Arm Description
Standard surgical treatment for symptomatic neuroma entailing neuroma excision.
Intervention Type
Device
Intervention Name(s)
AxoGuard® Nerve Cap
Intervention Description
Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
Intervention Type
Procedure
Intervention Name(s)
Standard Neurectomy
Intervention Description
Surgical excision of symptomatic neuroma
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) For Pain Score at 3 post-operative months in Pilot Phase Subjects
Description
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".
Time Frame
3 months
Title
Change in Visual Analog Scale (VAS) For Pain Score at 12 post-operative months in Comparative Phase Subjects.
Description
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".
Time Frame
12 months
Title
Safety: Serious Adverse Events (SAEs)
Description
The primary safety endpoint will compare the nature and incidence of SAEs between treatment groups
Time Frame
3 months
Title
Safety: Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs)
Description
The primary safety endpoint will compare the nature and incidence of AEs between treatment groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in Visual Analog Scale (VAS) For Pain score through 12 post-operative months compared to baseline.
Description
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".
Time Frame
1, 3, 6, 9, and 12 months
Title
2. Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through 12 post-operative months compared to baseline.
Description
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).
Time Frame
Time Frame: 1, 3, 6, 9 and 12 months
Title
Change in Foot Health Status Questionnaire (FHSQ) Score at 1,3,6,9, and 12 post-operative months compared to baseline.
Description
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.
Time Frame
Time Frame: 1, 3, 6, 9 and 12 months
Title
Changes in quantity, quality and class of pain medication use at 1,3,6,9 and 12 months comparted to baseline.
Description
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.
Time Frame
Time Frame: 1, 3, 6, 9 and 12 months
Title
SAEs, AEs, and/or UADEs
Description
The secondary safety endpoint will compare the nature and incidence of SAEs, AEs, and UADEs between treatment groups
Time Frame
6, 9, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Potential Subjects must): Be able and willing to provide documented informed consent prior to the conduct of any study procedures; Be an adult male or non-pregnant female ≥ 18 years of age; Report baseline pain scores of >65mm on a 100mm Visual Analog Scale (VAS) at screening; Have a documented diagnosis of symptomatic neuroma of at least one interdigital nerve in the foot which cannot be repaired to a distal nerve end; Must have 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 Be candidates indicated for surgery to address a symptomatic neuroma; Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap; 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; 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): Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions; Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc); Have a life expectancy of less than 12 months; Have a history of or planned radiotherapy in the area of the end-neuroma; 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; Have a history of chronic ischemic conditions of the extremity; Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator); Have a history of diabetic neuropathy; 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; Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure; Have a History of congenital neuropathy or compressive neuropathy affecting the target limb; Have a history of prior surgical management of more proximal compressive neuropathies or spinal conditions (e.g. spinal stenosis) not related to the symptomatic neuroma that affect the target limb; Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy; Be pregnant or plan to become pregnant during the duration of the study; Be or have been enrolled in another interventional study within 30 days prior to consenting; Have a known allergy to anesthetic agents; Have a known sensitivity to porcine derived materials; or Be, in the opinion of the Investigator, unsuitable for inclusion in the study.
Facility Information:
Facility Name
New Hope Podiatry Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90063
Country
United States
Facility Name
Anastasia Medical Group
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32080
Country
United States
Facility Name
EHI Clinical Research
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Gateway Clinical Trials
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
OrthoIllinois
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Foot and Ankle Center of Illinois
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Austin Foot and Ankle Specialists
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Complete Foot and Ankle Care of North Texas
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Foot & Ankle Institute
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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