Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma (NCT02718768) | Clinical Trial Compass
CompletedNot Applicable
Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
United States242 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
Timeframe: 2 years
2
Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Timeframe: 2 years
3
Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Timeframe: 2 years
4
Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
. 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).