Digital Nerve Injury, Digital Nerve Lesion, Nerve Injury, Nerve Reconstruction, Nerve Trauma
Conditions
Keywords
Nerve Repair, Therapeutic Electrical Stimulation, BES, Brief Electrical Stimulation
Brief summary
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.
Interventions
DEVICEBrief Electrical Stimulation Therapy
10-minutes of electrical stimulation to repaired nerve
PROCEDUREDigital Nerve Repair
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Sponsors
Checkpoint Surgical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two Point Discrimination | 2 weeks - 9 months | Evaluation of sensory function based on ability to discern two point of contact for different distances between the contacts (2-15mm). Evaluated at each follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semmes-Weinstein Monofilament Test | 2 weeks - 9 months | Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit. |
| Visual Analog Scale (VAS) | 2 weeks - 9 months | Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit. |
| quick Disabilities of Arm, Hand, and Shoulder (quickDASH) | 2 weeks - 9 months | Questionnaire providing patient reported estimate upper extremity function following injuries or disorders to the arm, hand, or shoulder. Responses to 11 questions answered on a 1-5 scale are used to calculate a scorescore ranging from 0 (no disability) to 100 (most severe disability). Evaluated at each follow-up visit. |
| Michigan Hand Outcomes Questionnaire (MHQ) | 2 weeks - 9 months | A patient reported questionnaire consisting of 37 questions answered on a 1-5 scale used to calculate an estimate of hand function on a 0-100 scale with a higher number indication greater hand function. Evaluated at each follow-up visit. |
Countries
United States
Contacts
Primary ContactDirector of Clincal Reseach
Outcome results
None listed