Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma

NCT02718768 | Completed DMC

• 1 other identifier: W81XWH-15-2-0074
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 17

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.

Conditions

Peripheral Nerve Injury(Ies)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Surgical Complications

  2 years

• Pain Score

  2 years

• Sensory Function

  2 years

• Motor Function

  2 years

• Global Hand Function

  2 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

450 Patients with PNI that meet the eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (17)

Denver Health

Denver, Colorado, United States

Location

Ryder Trauma Center

Miami, Florida, United States

Location

Methodist Hospital

Bloomington, Indiana, United States

Location

University of Maryland Medical Center Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

The Curtis National Hand Center, Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Location

MetroHealth

Cleveland, Ohio, United States

Location

University of Oklahoma Medicine

Oklahoma City, Oklahoma, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, United States

Location

University of Texas Health Science Center

Houston, Texas, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

Study Officials

• Jaimie Shores, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Lisa Reider, PhD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (17)