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

Not Applicable

Completed

Conditions: Morton's Neuroma
Chronic Nerve Pain
Symptomatic Neuroma

Interventions: Procedure: Standard Neurectomy
Device: AxoGuard® Nerve Cap

Registration Number: NCT03940963

Lead Sponsor: Axogen Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Neurectomy	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma entailing neuroma excision.
AxoGuard® Nerve Cap	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

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects	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 participant 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".
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months	3 months	The primary safety endpoint will compare the rate of SAEs related to the procedure or device between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months	3 months	The primary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Secondary Outcome Measures

Name	Time	Method
The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12	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.
Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.	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 (poorest state of foot health) to 100 (optimal foot health) with higher scores reflecting better foot health and quality of life.
As-Prescribed Opioid Medication	12 Months	Change from pre-operative baseline in quantity of pain medication prescribed via morphine milligram equivalent (MME) at 12 months Opioid pain medications prescribed were converted to morphine milligram equivalent (MME) where such conversions are available to summarize pain medications by quantity of use.
As-Taken Medication	12 Months	Change from baseline in average daily quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months. A daily pain medication log was provided to each participant to take home and complete each day and was collected at all visits. For opioid and non-opioid pain medications, the Medication Quantification Scale (MQS) Version III is a validated tool used to quantify the complexity and detriment of pain medication regimens. It calculates a single numeric value by combining medication detriment weights (ranging from 1.1 to 4.5) with dosage levels (scaled from 1 for subtherapeutic use to 4 for supratherapeutic use). A higher MQS score indicates greater potential medication detriment and/or dosage intensity. At 12 months, the study assessed changes from baseline in patients' average daily MQS scores.
Rate of Recurrence of Symptomatic Neuroma	12 Months	Symptomatic neuroma recurrence was defined as: 1. VAS pain score higher at 12 months than baseline 2. Opioid medications (MME) higher at 12 months than baseline 3. Participant-reported pain \>1 (on scale of 0-10) at least once between 9 months and 12 months. Participants experiencing all three of the criteria were determined to have symptomatic neuroma recurrence.
Total Reported Pain From Baseline to 12 Months	12 Months	Total pain experienced by participants over the course of study follow-up was calculated from the area under the curve (AUC) of daily pain log scores reported on a 0-10 numerical rating scale. An AUC value was calculated for each participant and normalized to the total possible AUC based on the number of log entries reported for that participant. The AUC scores are reported as a proportion of the total possible AUC (on a scale of 0-1) for a participant and difference in mean treatment group values tested by a t-test.
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 6 Months	6 Months	The secondary safety endpoint will compare the rate of procedure- or device-related SAEs between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 6 Months	6 Months	The secondary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months	9 Months	The secondary safety endpoint will compare the rate of procedure- or device-related SAEs between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months	9 Months	The secondary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months	12 Months	The secondary safety endpoint will compare the rate of procedure- or device-related SAEs between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months	12 Months	The secondary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Trial Locations

Locations (11): New Hope Podiatry Group
🇺🇸
Los Angeles, California, United States
Gateway Clinical Trials
🇺🇸
O'Fallon, Illinois, United States
EHI Clinical Research
🇺🇸
Roswell, Georgia, United States
Anastasia Medical Group
🇺🇸
Saint Augustine, Florida, United States
OrthoIllinois
🇺🇸
Rockford, Illinois, United States
Foot and Ankle Center of Illinois
🇺🇸
Springfield, Illinois, United States
Complete Foot and Ankle Care of North Texas
🇺🇸
Denton, Texas, United States
JPS Health Network
🇺🇸
Fort Worth, Texas, United States
Foot & Ankle Institute
🇺🇸
Saint George, Utah, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Austin Foot and Ankle Specialists
🇺🇸
Austin, Texas, United States