REPOSE
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
Sponsor study identifier
interventional
86
1 country
11
Study Start
October 10, 2018
Actual (reported)Primary Completion
July 17, 2023
Actual (reported)Study Completion
July 17, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 17, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2018
Actual (reported)May 6, 2019
Actual (reported)May 7, 2019
Actual (reported)July 17, 2023
Actual (reported)July 17, 2023
Actual (reported)January 9, 2025
Actual (reported)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
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.
Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
Surgical excision of symptomatic neuroma
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New Hope Podiatry Group
Los Angeles, California, 90063, United States
Anastasia Medical Group
Saint Augustine, Florida, 32080, United States
EHI Clinical Research
Roswell, Georgia, 30076, United States
Gateway Clinical Trials
O'Fallon, Illinois, 62269, United States
OrthoIllinois
Rockford, Illinois, 61107, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Each study site followed their standard post-operative care instructions. Variability in surgical technique for neurectomy procedures exists across study sites. The study considered sensory nerves in the foot and ankle and may be relevant to other nerve types and anatomic locations where symptomatic neuroma treatment is similar. Recurrence of neuroma was not diagnosed in the study, and additional follow-up may identify a recurrence of neuroma in some patients.
86 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2019
First Posted
May 7, 2019
Study Start
October 10, 2018
Actual (reported)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
The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12
12 months
Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.
12 months
As-Prescribed Opioid Medication
12 Months
As-Taken Medication
12 Months
Rate of Recurrence of Symptomatic Neuroma
12 Months
Contact the study team to confirm eligibility.
Austin Foot and Ankle Specialists
Austin, Texas, 78746, United States
Complete Foot and Ankle Care of North Texas
Denton, Texas, 76210, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Foot & Ankle Institute
St. George, Utah, 84770, United States
Primary Completion
July 17, 2023
Actual (reported)Study Completion
July 17, 2023
Actual (reported)Last Updated
January 9, 2025
Results First Posted
January 9, 2025
Record last verified: 2024-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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