Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries

Description

The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

Conditions

Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma, Digital Nerve Lesion

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Study Overview

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Study Details

Study overview

The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves

Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries

Condition
Digital Nerve Injury
Intervention / Treatment

-

Contacts and Locations

St. Louis

Washington University in St Louis, Department of Orthopedic Surgery, St. Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-80 years
  • * Candidate for surgical intervention under general anesthesia.
  • * Require primary nerve injury repair in at least 1 digital nerve.
  • * Following resection, have a resulting nerve gap of ≤ 10mm.
  • * Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm
  • * Signed and dated informed consent form.
  • * Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
  • * Nerve repair occurring \>1 month post-injury.
  • * Incomplete nerve transection.
  • * Injury requiring replantation of target digit
  • * Injury distal to the distal interphalangeal joint.
  • * Injury proximal to branching into the proper or common digital nerves.
  • * Injuries to both digital arteries of an affected digit.
  • * History of neuropathy, diabetic neuropathy, or any other known neuropathy
  • * History of chronic ischemic condition of the upper extremity
  • * Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Checkpoint Surgical Inc.,

Study Record Dates

2027-03