Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard of Care Repair |
Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon. |
|
|
Experimental Repair + Therapy |
During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery. |
|
Recruiting Locations
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri 65212
Columbia, Missouri 65212
Washington University in St Louis, Department of Orthopedic Surgery
St. Louis, Missouri 63110
St. Louis, Missouri 63110
Contact:
Clinical Reseach Coordinator
(314) 454-5967
Clinical Reseach Coordinator
(314) 454-5967
More Details
- NCT ID
- NCT06867185
- Status
- Recruiting
- Sponsor
- Checkpoint Surgical Inc.