Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma (Nerve)

A Multi Center Prospective Observational 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Nerve Injury(Ies)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States
      • Denver Health
  • Florida
    • Miami, Florida, United States
      • Ryder Trauma Center
  • Indiana
    • Bloomington, Indiana, United States
      • Methodist Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center Shock Trauma Center
    • Baltimore, Maryland, United States
      • The Curtis National Hand Center, Medstar Union Memorial Hospital
    • Bethesda, Maryland, United States
      • Walter Reed National Military Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Hennepin County Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico Health Sciences Center
  • North Carolina
    • Charlotte, North Carolina, United States
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States
      • MetroHealth
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • University of Oklahoma Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Pennsylvania Hospital
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt Medical Center
  • Texas
    • Houston, Texas, United States
      • University of Texas Health Science Center
    • San Antonio, Texas, United States
      • San Antonio Military Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

450 Patients with PNI that meet the eligibility criteria.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Pain Score	Self reported outcomes using the Brief Pain Inventory.	2 years
Sensory Function	Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.	2 years
Motor Function	Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale.	2 years
Global Hand Function	Global hand function will be measured using grip strength.	2 years
Disability	Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).	2 years
Depression	Self reported outcomes using the Patient Health Questionnaire (PHQ-9).	2 years
Post Traumatic Stress Disorder (PTSD)	Self reported outcomes using the standard PTSD Checklist.	2 years
Return to Work or Duty	Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire.	2 years

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium
• Investigators: Principal Investigator: Jaimie Shores, MD, Johns Hopkins University; Study Director: Lisa Reider, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimated): March 24, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: W81XWH-15-2-0074