Clinical trial NCT02718768: Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
Official title: A Multi Center Prospective Observational Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Injury(Ies)
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 450 Patients with PNI that meet the eligibility criteria.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
timeFrame: 2 years
measure: Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
timeFrame: 2 years
measure: Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
timeFrame: 2 years
measure: Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
timeFrame: 2 years
Secondary outcomes:
measure: Surgical Complications
timeFrame: 2 years
measure: Pain Score
timeFrame: 2 years
measure: Sensory Function
timeFrame: 2 years
measure: Motor Function
timeFrame: 2 years
measure: Global Hand Function
timeFrame: 2 years
measure: Disability
timeFrame: 2 years
measure: Depression
timeFrame: 2 years
measure: Post Traumatic Stress Disorder (PTSD)
timeFrame: 2 years
measure: Return to Work or Duty
timeFrame: 2 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Miami
country: United States
facility: Ryder Trauma Center
state: Florida
city: Bloomington
country: United States
facility: Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center Shock Trauma Center
state: Maryland
city: Baltimore
country: United States
facility: The Curtis National Hand Center, Medstar Union Memorial Hospital
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Medicine
state: Oklahoma
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Jaimie Shores, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lisa Reider, PhD
role: STUDY_DIRECTOR
References: