Clinical trial NCT03940963: Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.


Eligibility 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 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.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects
timeFrame: 12 months
measure: The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months
timeFrame: 3 months
measure: The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12
timeFrame: 12 months
measure: Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.
timeFrame: 12 months
measure: As-Prescribed Opioid Medication
timeFrame: 12 Months
measure: As-Taken Medication
timeFrame: 12 Months
measure: Rate of Recurrence of Symptomatic Neuroma
timeFrame: 12 Months
measure: Total Reported Pain From Baseline to 12 Months
timeFrame: 12 Months
measure: The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 6 Months
timeFrame: 6 Months
measure: The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 6 Months
timeFrame: 6 Months
measure: The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months
timeFrame: 9 Months
measure: The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months
timeFrame: 9 Months
measure: The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months
timeFrame: 12 Months
measure: The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: New Hope Podiatry Group
state: California
city: Saint Augustine
country: United States
facility: Anastasia Medical Group
state: Florida
city: Roswell
country: United States
facility: EHI Clinical Research
state: Georgia
city: O'Fallon
country: United States
facility: Gateway Clinical Trials
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Springfield
country: United States
facility: Foot and Ankle Center of Illinois
state: Illinois
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Austin
country: United States
facility: Austin Foot and Ankle Specialists
state: Texas
city: Denton
country: United States
facility: Complete Foot and Ankle Care of North Texas
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: Saint George
country: United States
facility: Foot & Ankle Institute
state: Utah
Study officials:
References: