Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
- Conditions
- Peripheral Nerve Injury(Ies)
- Registration Number
- NCT02718768
- Lead Sponsor
- Major Extremity Trauma Research Consortium
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
-
Ages 18-65
-
Sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria:
- 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
- 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.
-
Receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury.
- Injuries to the brachial plexus roots, trunks, divisions and cords
- Injuries to the nerves distal to the distal flexion crease of the wrist
- Injuries that involve a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral ante brachial cutaneous nerve, etc)
- Previous motor or sensory deficit prior to injury (e.g. resulting from trauma, stroke, muscular, neurologic, neuromuscular disorder, etc.)
- Documented psychiatric disorder that limits ability to consent and maintain follow-up
- Unable to speak either English or Spanish
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers. 2 years Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers. 2 years Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers. 2 years Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers. 2 years
- Secondary Outcome Measures
Name Time Method Pain Score 2 years Self reported outcomes using the Brief Pain Inventory.
Global Hand Function 2 years Global hand function will be measured using grip strength.
Surgical Complications 2 years 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.
Disability 2 years Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).
Sensory Function 2 years Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
Depression 2 years Self reported outcomes using the Patient Health Questionnaire (PHQ-9).
Return to Work or Duty 2 years Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire.
Motor Function 2 years Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale.
Post Traumatic Stress Disorder (PTSD) 2 years Self reported outcomes using the standard PTSD Checklist.
Trial Locations
- Locations (17)
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ryder Trauma Center
🇺🇸Miami, Florida, United States
Methodist Hospital
🇺🇸Bloomington, Indiana, United States
University of Maryland Medical Center Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
The Curtis National Hand Center, Medstar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
MetroHealth
🇺🇸Cleveland, Ohio, United States
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Oklahoma Medicine
🇺🇸Oklahoma City, Oklahoma, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Denver Health
🇺🇸Denver, Colorado, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States