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

Status: Completed
Location: See all (11) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
New Hope Podiatry Group
Los Angeles
Florida
Anastasia Medical Group
Saint Augustine
Georgia
EHI Clinical Research
Roswell
Illinois
Gateway Clinical Trials
O'fallon
OrthoIllinois
Rockford
Foot and Ankle Center of Illinois
Springfield
Ohio
The Ohio State University
Columbus
Texas
Austin Foot and Ankle Specialists
Austin
Complete Foot and Ankle Care of North Texas
Denton
JPS Health Network
Fort Worth
Utah
Foot & Ankle Institute
St. George
Time Frame
Start Date: 2018-10-10
Completion Date: 2023-07-17
Participants
Target number of participants: 86
Treatments
Active_comparator: AxoGuard® Nerve Cap
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.
Active_comparator: Standard Neurectomy
Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Sponsors
Leads: Axogen Corporation

This content was sourced from clinicaltrials.gov