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

January 21, 2025 updated by: Major Extremity Trauma Research Consortium

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
Time Frame: 2 years
2 years
Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time Frame: 2 years
2 years
Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time Frame: 2 years
2 years
Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2 years
Pain Score
Time Frame: 2 years
Self reported outcomes using the Brief Pain Inventory.
2 years
Sensory Function
Time Frame: 2 years
Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
2 years
Motor Function
Time Frame: 2 years
Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale.
2 years
Global Hand Function
Time Frame: 2 years
Global hand function will be measured using grip strength.
2 years
Disability
Time Frame: 2 years
Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).
2 years
Depression
Time Frame: 2 years
Self reported outcomes using the Patient Health Questionnaire (PHQ-9).
2 years
Post Traumatic Stress Disorder (PTSD)
Time Frame: 2 years
Self reported outcomes using the standard PTSD Checklist.
2 years
Return to Work or Duty
Time Frame: 2 years
Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Major Extremity Trauma Research Consortium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaimie Shores, MD, Johns Hopkins University
  • Study Director: Lisa Reider, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W81XWH-15-2-0074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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