NCT Number: NCT02718768
Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Denver Health, Denver, Colorado, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Treatment and study plan
Primary outcomes
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Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
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Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
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Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
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Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
Secondary outcomes
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Surgical Complications
Time frame: 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.
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Pain Score
Time frame: 2 years
Self reported outcomes using the Brief Pain Inventory.
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Sensory Function
Time frame: 2 years
Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
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Motor Function
Time frame: 2 years
Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale.
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Global Hand Function
Time frame: 2 years
Global hand function will be measured using grip strength.
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Disability
Time frame: 2 years
Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).
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Depression
Time frame: 2 years
Self reported outcomes using the Patient Health Questionnaire (PHQ-9).
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Post Traumatic Stress Disorder (PTSD)
Time frame: 2 years
Self reported outcomes using the standard PTSD Checklist.
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Return to Work or Duty
Time frame: 2 years
Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire.
Sponsors and collaborators
Lead sponsor
Major Extremity Trauma Research Consortium
Other
Registry information
Official study title
A Multi Center Prospective Observational Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
Acronym: Nerve
Important dates
- Study start
- 2016
- Primary completion
- 2021
- Study completion
- 2024
- First posted
- Mar 24, 2016
- Registry last updated
- Jan 23, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.