Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of … (NCT03940963) | Clinical Trial Compass
CompletedNot Applicable
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
United States86 participantsStarted 2018-10-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. 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;
âś“. Report baseline pain scores of \>65mm on a 100mm Visual Analog Scale (VAS) at screening;
âś“. 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;
âś“. Must have the of the following:
âś“. 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;
Exclusion criteria
âś•. Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
âś•. Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
âś•. Have a life expectancy of less than 12 months;
âś•
What they're measuring
1
Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects
Timeframe: 12 months
2
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months
Timeframe: 3 months
3
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months
. Have a history of or planned radiotherapy in the area of the end-neuroma;
âś•. 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;
âś•. Have a history of chronic ischemic conditions of the extremity;
âś•. Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);