Peripheral Nerve Injury(Ies) Clinical Trial
— NerveOfficial title:
A Multi Center Prospective Observational Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
| Verified date | January 2024 |
| Source | Major Extremity Trauma Research Consortium |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a multi-center prospective observational study that will capture detailed information about the treatment and long term outcomes of 250 patients with PNI resulting from upper extremity trauma. The study will focus on a young adult population to include individuals ages 18-65. Patients with PNI will be recruited during the hospitalization for initial treatment of the upper extremity injury. Additional patients may be identified during clinic visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon referral from outside physicians. However, all eligible nerve injuries must be treated within 6 months of the initial upper extremity trauma. Outcomes will be assessed at 3, 6, 12, 18 and 24 months following diagnosis of the nerve injury. All assessments will take place in the clinic and will include a patient interview and a brief exam to evaluate sensory and motor function.
| Status | Active, not recruiting |
| Enrollment | 250 |
| Est. completion date | July 2024 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: 1. Ages 18-65 2. Sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria: 1. Involves injury or dysfunction to motor, or motor and sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized distal to the brachial plexus cord level and proximal to the distal flexion crease of the wrist 2. Involves a "mixed" nerve segment (i.e. involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present) but does not include sensory only distal terminations of the same nerves. 3. Receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury. Exclusion Criteria: 1. Injuries to the brachial plexus roots, trunks, divisions and cords 2. Injuries to the nerves distal to the distal flexion crease of the wrist 3. Injuries that involve a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral ante brachial cutaneous nerve, etc) 4. Previous motor or sensory deficit prior to injury (e.g. resulting from trauma, stroke, muscular, neurologic, neuromuscular disorder, etc.) 5. Documented psychiatric disorder that limits ability to consent and maintain follow-up 6. Unable to speak either English or Spanish 7. Severe problems with maintaining follow up (e.g patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support). |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
| United States | The Curtis National Hand Center, Medstar Union Memorial Hospital | Baltimore | Maryland |
| United States | University of Maryland Medical Center Shock Trauma Center | Baltimore | Maryland |
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Methodist Hospital | Bloomington | Indiana |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | MetroHealth | Cleveland | Ohio |
| United States | Denver Health | Denver | Colorado |
| United States | University of Texas Health Science Center | Houston | Texas |
| United States | Ryder Trauma Center | Miami | Florida |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | Vanderbilt Medical Center | Nashville | Tennessee |
| United States | University of Oklahoma Medicine | Oklahoma City | Oklahoma |
| United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
| United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
| United States | San Antonio Military Medical Center | San Antonio | Texas |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Major Extremity Trauma Research Consortium |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers. | 2 years | ||
| Primary | Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers. | 2 years | ||
| Primary | Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers. | 2 years | ||
| Primary | Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers. | 2 years | ||
| Secondary | Surgical Complications | Surgical complications includes surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair and reconstruction, seroma/hematoma, and other local wound complications. | 2 years | |
| Secondary | Pain Score | Self reported outcomes using the Brief Pain Inventory. | 2 years | |
| Secondary | Sensory Function | Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit. | 2 years | |
| Secondary | Motor Function | Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale. | 2 years | |
| Secondary | Global Hand Function | Global hand function will be measured using grip strength. | 2 years | |
| Secondary | Disability | Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). | 2 years | |
| Secondary | Depression | Self reported outcomes using the Patient Health Questionnaire (PHQ-9). | 2 years | |
| Secondary | Post Traumatic Stress Disorder (PTSD) | Self reported outcomes using the standard PTSD Checklist. | 2 years | |
| Secondary | Return to Work or Duty | Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire. | 2 years |