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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Repair | Active Comparator | Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon. |
|
| Repair + Therapy | Experimental | During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Electrical Stimulation Therapy | Device | 10-minutes of electrical stimulation to repaired nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two Point Discrimination | 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. | 2 weeks - 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Semmes-Weinstein Monofilament Test | Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit. | 2 weeks - 9 months |
| Visual Analog Scale (VAS) | Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clincal Reseach | Contact | 877-478-9106 | clinical@checkpointsurgical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Hand to Shoulder Center | Recruiting | Indianapolis | Indiana | 46260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35139047 | Background | Roh J, Schellhardt L, Keane GC, Hunter DA, Moore AM, Snyder-Warwick AK, Mackinnon SE, Wood MD. Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. Plast Reconstr Surg. 2022 Apr 1;149(4):681e-690e. doi: 10.1097/PRS.0000000000008924. | |
| 34668879 |
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| Digital Nerve Repair | Procedure | Standard of care surgical repair of digital nerve injury as determined by health care provider. |
|
|
| 2 weeks - 9 months |
| quick Disabilities of Arm, Hand, and Shoulder (quickDASH) | 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. | 2 weeks - 9 months |
| Michigan Hand Outcomes Questionnaire (MHQ) | 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. | 2 weeks - 9 months |
| University of Missouri Department of Orthopaedic Surgery | Recruiting | Columbia | Missouri | 65212 | United States |
|
| Washington University in St Louis, Department of Orthopedic Surgery | Recruiting | St Louis | Missouri | 63110 | United States |
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| The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery | Recruiting | Columbus | Ohio | 43212 | United States |
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| Harborview Medical Center - University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
|
| Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965. |
| 38600968 | Background | Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available. |
| 25727139 | Background | Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4. |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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