The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity Trauma (MBTK)

The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus.

Study Overview

• Status: Recruiting
• Conditions: Gait
• Intervention / Treatment: Other: None- Observational Study

Detailed Description

The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. All participating centers will undergo training to implement the Mobility Toolkit (MTK). Research Staff will facilitate a series of performance tests while participants wear the MTK device. MTK assessment will also be conducted on 150 non-injured adults matched to the injured cohort on age and gender. These individuals will be enrolled and assessed once at two participating centers. Study flow and data capture are summarized in the figure on the next page.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: ELIZABETH WYSOCKI, MS; Phone Number: 4109550396; Email: ewysock2@jhu.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
      • Principal Investigator: Paul Matuszewski, MD
      • Contact: Paul Stringer, BS; Email: paul.stringer@uky.edu
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland R Adams Cowley Shock Trauma Center
      • Principal Investigator: Robert O'Toole, MD
    • Bethesda, Maryland, United States, 20889
      • Not yet recruiting
      • Walter Reed National Military Medical Center
      • Contact: Kyle Potter, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Barnes Jewish Hospital
      • Principal Investigator: William Ricci, MD
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Not yet recruiting
      • Mission Hospital
      • Principal Investigator: Harold Frisch, MD
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Carolinas Medical Center
      • Principal Investigator: Michael J Bosse, MD
    • Fort Bragg, North Carolina, United States, 28100
      • Not yet recruiting
      • Womack Army Medical Center at Ft. Bragg
      • Principal Investigator: Kenneth Nelson, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: William T. Obremskey, MD, MPH
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • University of Texas Health Science Center - Houston
      • Principal Investigator: Joshua Gary, MD
    • San Antonio, Texas, United States, 78234
      • Not yet recruiting
      • San Antonio Military Medical Center (SAMMC)
      • Principal Investigator: Sarah Pierrie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults ages 18-60 surgically treated for a fracture of the tibial plateau, pilon, ankle, or calcaneus at one of 10 participating centers. Patients meeting the inclusion and exclusion criteria will approached for enrollment in to the study.

Description

Inclusion Criteria:

1. 18-60 years of age
2. Open or closed fractures of the tibial plateau, pilon, ankle or calcaneus requiring surgical fixation.

Exclusion Criteria:

1. Gustilo type IIIB or IIIC injuries
2. No other surgically or non-surgically treated injuries that impact gait (e.g. upper extremity injury proximal to the elbow; spinal cord injury; contralateral or ipsilateral fractures).
3. Neurologic impairment or deficit that impairs gait
4. Prior injuries or conditions that alter gait (e.g. severe osteoarthritis)
5. Severe problems with maintaining follow-up (e.g. participants who are prisoners, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
6. Unable to provide informed consent in English or Spanish.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Injured Cohort; Approximately 300 participants treated for a fracture of the tibial plateau, pilon, ankle or calcaneus will be enrolled from METRC civilian trauma centers and military treatment facilities over an 18 month period. Participating centers treat large numbers of severe orthopaedic injuries and have a proven track record for successfully recruiting and retaining participants in prospective studies in orthopaedic trauma. Participants will be enrolled following definitive treatment of their injury.	Other: None- Observational Study; No Intervention
Non-Injured Volunteers; Non-injured adults of similar age and gender distribution will be enrolled at two participating centers (Carolinas Medical Center and Womack Military Medical Center). The sample of non-injured volunteers will exclude individuals with history of lower extremity injury, vascular disease, or who require use of ambulatory aides to walk.	Other: None- Observational Study; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use of the Mobility Toolkit during clinic	Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.	12 months
Satisfaction of the Mobility Toolkit	Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits.	12 months
Gait Quality assessed with Mobility Tooklkit	Gait Quality will be measured using the MTK to assess gait parameters such as lift acceleration, step time asymmetry, and peak-to-peak upper body pitch and roll.	12 months
Gait Quality assessed by performance tests	Gait will be assessed while completing three performance tests: 10 meter walk, sit to stand, and timed up and go (TUG) Injured participants will be assessed at time of first weight bearing, and at clinic visits 3, 6 and 12 months following definitive treatment.	Change in gate from measured at 3, 6 & 12 months
Physical Function	Patient Reported Function will be assessed using the physical function item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.	Change in physical function measured at 3, 6, & 12 months
Pain Score	Patient Reported Pain will be assessed using the pain interference item banks from the Patient Reported Outcomes Measurement Information System (PROMIS). Injured participants will be assessed at baseline and at each follow-up visit.	Change in pain score measured at 3, 6, & 12 months
Number of patient complications resulting from injury	Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment.	12 months

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium
• Investigators: Principal Investigator: Stephen Sims, MD, Carolinas Medical Center; Principal Investigator: Lisa Reider, PhD, JHSPH/METRC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: W81XWH-18-1-0815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium.

Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No