Symptomatic NeuromaREPOSENCT03940963
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
A study testing AxoGuard® Nerve Cap and Standard Neurectomy in people with Symptomatic Neuroma and Morton's Neuroma, run by Axogen Corporation at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
- What is being tested?
- AxoGuard® Nerve Cap and Standard Neurectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 11 sitesUnited States
- Study dates
- 10 Oct 2018to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Austin Foot and Ankle Specialists
Austin, Texas, 78746
The Ohio State University
Columbus, Ohio, 43210
Complete Foot and Ankle Care of North Texas
Denton, Texas, 76210
JPS Health Network
Fort Worth, Texas, 76104
New Hope Podiatry Group
Los Angeles, California, 90063
Gateway Clinical Trials
O'Fallon, Illinois, 62269
OrthoIllinois
Rockford, Illinois, 61107
EHI Clinical Research
Roswell, Georgia, 30076
Anastasia Medical Group
Saint Augustine, Florida, 32080
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704
Foot & Ankle Institute
St. George, Utah, 84770
About this study
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
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.
- Conditions
- Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
- Being tested
- AxoGuard® Nerve Cap, Standard Neurectomy
- 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
- Medical subject headings
- Morton Neuroma, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxoGuard® Nerve CapDevice
Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
Standard NeurectomyProcedure or surgery
Surgical excision of symptomatic neuroma
| Study group | Role | What they receive |
|---|---|---|
| AxoGuard® Nerve Cap | Active comparator | Porcine derived extracellular matrix (ECM) based Nerve Termination Device.
Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve. Receives: Device: AxoGuard® Nerve Cap |
| Standard Neurectomy | Active comparator | Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap). Receives: Procedure: Standard Neurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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".
Measured: 12 months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 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.
Measured: 3 months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 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.
Measured: 3 months
Secondary outcomes (12)
The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12
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.
Measured: 12 months
Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 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 (poorest state of foot health) to 100 (optimal foot health) with higher scores reflecting better foot health and quality of life.
Measured: 12 months
As-Prescribed Opioid Medication
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.
Measured: 12 Months
As-Taken Medication
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.
Measured: 12 Months
Rate of Recurrence of Symptomatic Neuroma
Symptomatic neuroma recurrence was defined as:
- VAS pain score higher at 12 months than baseline
- Opioid medications (MME) higher at 12 months than baseline
- 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.
Measured: 12 Months
Total Reported Pain From Baseline to 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.
Measured: 12 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 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.
Measured: 6 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 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.
Measured: 6 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 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.
Measured: 9 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 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.
Measured: 9 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 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.
Measured: 12 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start10 Oct 2018
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940963
- Sponsor's protocol ID
- CAP-CP-001
- Acronym
- REPOSE
- Status last verified
- Dec 2024
- First submitted
- 6 May 2019
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03940963
- Acronym / sponsor ID
- REPOSE / CAP-CP-001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AxoGuard® Nerve Cap | Active comparator | Device: AxoGuard® Nerve CapPorcine derived extracellular matrix (ECM) based Nerve Termination Device. Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve. |
| Standard Neurectomy | Active comparator | Procedure: Standard NeurectomyStandard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AxoGuard® Nerve CapEntubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma | Device | AxoGuard® Nerve Cap |
| Standard NeurectomySurgical excision of symptomatic neuroma | Procedure or surgery | Standard Neurectomy |
Primary outcome
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 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
Time frame: 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
Time frame: 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.
12 secondary outcomes
The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12
Time frame: 12 months
Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.
Time frame: 12 months
As-Prescribed Opioid Medication
Time frame: 12 Months
As-Taken Medication
Time frame: 12 Months
Rate of Recurrence of Symptomatic Neuroma
Time frame: 12 Months
Total Reported Pain From Baseline to 12 Months
Time frame: 12 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 6 Months
Time frame: 6 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 6 Months
Time frame: 6 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months
Time frame: 9 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months
Time frame: 9 Months
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months
Time frame: 12 Months
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AxoGuard® Nerve Cap and Standard Neurectomy in people with Symptomatic Neuroma and Morton's Neuroma, run by Axogen Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.