Peripheral Nerve Injury(Ies)NerveNCT02718768
Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
An observational study of Peripheral Nerve Injury(Ies), run by Major Extremity Trauma Research Consortium at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injury(Ies)
- How many people
- 242 participants
- Where
- 17 sitesUnited States
- Study dates
- Mar 2016to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 450 Patients with PNI that meet the eligibility criteria.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico
University of Maryland Medical Center Shock Trauma Center
Baltimore, Maryland, 21201
The Curtis National Hand Center, Medstar Union Memorial Hospital
Baltimore, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland
Methodist Hospital
Bloomington, Indiana
Carolinas Medical Center
Charlotte, North Carolina
MetroHealth
Cleveland, Ohio
Denver Health
Denver, Colorado
University of Texas Health Science Center
Houston, Texas
Ryder Trauma Center
Miami, Florida
Hennepin County Medical Center
Minneapolis, Minnesota
Vanderbilt Medical Center
Nashville, Tennessee
University of Oklahoma Medicine
Oklahoma City, Oklahoma
Pennsylvania Hospital
Philadelphia, Pennsylvania
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
San Antonio Military Medical Center
San Antonio, Texas
Wake Forest Baptist Health
Winston-Salem, North Carolina
About this study
Official title: 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.
- Conditions
- Peripheral Nerve Injury(Ies)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
Measured: 2 years
Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Measured: 2 years
Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Measured: 2 years
Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Measured: 2 years
Secondary outcomes (9)
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.
Measured: 2 years
Pain Score
Self reported outcomes using the Brief Pain Inventory.
Measured: 2 years
Sensory Function
Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
Measured: 2 years
Motor Function
Motor function will be evaluated using range of motion and the British Medical Research Council motor grading scale.
Measured: 2 years
Global Hand Function
Global hand function will be measured using grip strength.
Measured: 2 years
Disability
Self reported outcomes using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).
Measured: 2 years
Depression
Self reported outcomes using the Patient Health Questionnaire (PHQ-9).
Measured: 2 years
Post Traumatic Stress Disorder (PTSD)
Self reported outcomes using the standard PTSD Checklist.
Measured: 2 years
Return to Work or Duty
Self reported outcomes using the Work Productivity and Activity Impairment (WPAI) questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2021
- Study completionJul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Injury(Ies)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaimie Shores, MD, Principal investigator, Johns Hopkins UniversityLisa Reider, PhD, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718768
- Sponsor's protocol ID
- W81XWH-15-2-0074
- Acronym
- Nerve
- Status last verified
- Jan 2025
- First submitted
- 11 Mar 2016
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Prospective Observational Study of Nerve Repair and Reconstruction Associated With Major Extremity Trauma
- ClinicalTrials.gov ID
- NCT02718768
- Acronym / sponsor ID
- Nerve / W81XWH-15-2-0074
- Conditions
- Peripheral Nerve Injury(Ies)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 450 Patients with PNI that meet the eligibility criteria.
Key inclusion criteria (5 listed)
- Ages 18-65
- Sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria:
- Receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
Type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
Treatment type of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
Treatment timing of PNI resulting from upper extremity trauma admitted across multiple trauma centers.
Time frame: 2 years
9 secondary outcomes
Surgical Complications
Time frame: 2 years
Pain Score
Time frame: 2 years
Sensory Function
Time frame: 2 years
Motor Function
Time frame: 2 years
Global Hand Function
Time frame: 2 years
Disability
Time frame: 2 years
Depression
Time frame: 2 years
Post Traumatic Stress Disorder (PTSD)
Time frame: 2 years
Return to Work or Duty
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimie Shores, MD principal investigator
Johns Hopkins University
Lisa Reider, PhD study director
Johns Hopkins Bloomberg School of Public Health
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injury(Ies), run by Major Extremity Trauma Research Consortium at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Peripheral Nerve Injury (PNI) resulting from upper extremity trauma admitted across multiple trauma centers. (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.