Study of AxoGuard® Nerve Cap and Neurectomy for Treatment... | NCT03940963

Status Module

Label	Type	Description	Intervention Names
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.	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).	Procedure: Standard Neurectomy

Name	Type	Description	Arm Group Labels	Other Names
AxoGuard® Nerve Cap	Device	Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma	AxoGuard® Nerve Cap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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".	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.	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.	3 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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	Status	City	State	ZIP	Country	Contacts
New Hope Podiatry Group		Los Angeles	California	90063	United States
Anastasia Medical Group

ID	Title	Description
FG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
FG001	Standard Neurectomy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 1, 2021	Oct 29, 2024

ID	Title	Description
BG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
BG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00041 BG00143 BG00284

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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".

Intent-to-treat (ITT) population, including all participants who were randomized, received the study device or underwent neurectomy, and completed at least one post-baseline assessment of efficacy. Analysis is based on treatment as randomized.

Posted

Mean

95% Confidence Interval

Millimeters (mm)

12 months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants	OG00030 OG00135

Title

Denominators

Categories

Title	Measurements
	OG000-86.62(-95.21 to -78.03) OG001-72.67(-81.02 to -64.32)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.011	The threshold for statistical significance was p = 0.05.													Non-Inferiority	The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.

Primary

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.

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Primary

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.

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

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.

Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Posted

Mean

Inter-Quartile Range

Pain Behavior Scale Score

12 months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy

Secondary

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.

Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Posted

Mean

Inter-Quartile Range

FHSQ Score

12 months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units

Secondary

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.

Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Posted

Mean

Full Range

Morphine Milligram Equivalent

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

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.

Analysis population derived from modified intent-to-treat (mITT) population participants that completed at least one post-baseline assessment of efficacy and reported medications in diary. Analysis was based on the treatment as received

Posted

Mean

Inter-Quartile Range

MQS Units/Day

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Secondary

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.

Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

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.

This is the per-protocol (PP) population which includes all participants in the mITT population who have an endpoint for the analysis in question and have experienced no conditions that may confound study outcomes, such as sustaining a foot injury during study follow-up. Analysis is based on the treatment as received.

Posted

Mean

Inter-Quartile Range

Proportion of Area Under Pain*Time Curve

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Secondary

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.

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Treatment assignment is based on treatment as received.

Posted

Count of Participants

Participants

6 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

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.

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

6 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Treatment assignment is based on treatment as received.

Posted

Count of Participants

Participants

9 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

9 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Secondary

The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months

This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
OG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
IMPAIRED HEALING	General disorders	Systematic Assessment	Anticipated risk of a surgical procedure	EG0001 affected41 at risk EG0010 affected43 at risk
APPENDICITIS	Infections and infestations	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
COVID-19 PNEUMONIA	Infections and infestations	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk
NEUROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	Systematic Assessment	Determined to be unrelated to treatment	EG0001 affected41 at risk EG0010 affected43 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	Determined to be unrelated to treatment	EG0000 affected41 at risk EG0011 affected43 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
NODULE	General disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
OEDEMA	General disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
PERIPHERAL SWELLING	General disorders	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
CELLULITIS	Infections and infestations	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0001 affected41 at risk EG0011 affected43 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
SINUSITIS	Infections and infestations	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
INCISION SITE ERYTHEMA	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
INCISION SITE PAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected41 at risk EG0011 affected43 at risk
INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
STRESS FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
VACCINATION COMPLICATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
BURSAL FLUID ACCUMULATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
METATARSALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected41 at risk EG0012 affected43 at risk
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected41 at risk EG0011 affected43 at risk
PLANTAR FASCIITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected41 at risk EG0011 affected43 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
NEUROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected41 at risk EG0012 affected43 at risk
SKIN PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected41 at risk EG0011 affected43 at risk
HYPOAESTHESIA	Nervous system disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
NERVE COMPRESSION	Nervous system disorders	Systematic Assessment	EG0000 affected41 at risk EG0014 affected43 at risk
NEURALGIA	Nervous system disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	Systematic Assessment	EG0001 affected41 at risk EG0011 affected43 at risk
PARAESTHESIA	Nervous system disorders	Systematic Assessment	EG0001 affected41 at risk EG0010 affected43 at risk
EXCESSIVE GRANULATION TISSUE	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
INGROWING NAIL	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
ESSENTIAL HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0000 affected41 at risk EG0011 affected43 at risk

ID	Term
D000070607	Morton Neuroma
D059348	Peripheral Nerve Injuries
D010523	Peripheral Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

ID	Term
D037061	Metatarsalgia
D005534	Foot Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases
D009437	Neuralgia
D009468	Neuromuscular Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AxoGuard® Nerve Cap	Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	0	41	6	41	16	41
EG001	Standard Neurectomy	Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).	0	43	5	43	16	43