Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries (FASTR-TEN)

Checkpoint Surgical

Status: Enrolling

Conditions: Nerve Reconstruction; Digital Nerve Injury; Nerve Trauma; Digital Nerve Lesion; Nerve Injury

Treatments: Procedure: Digital Nerve Repair; Device: Brief Electrical Stimulation Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06867185

0153-CSP-300

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard of Care Repair

Active Comparator group

Description:

Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.

Treatment:

Procedure: Digital Nerve Repair

Repair + Therapy

Experimental group

Description:

During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.

Treatment:

Device: Brief Electrical Stimulation Therapy

Procedure: Digital Nerve Repair