Gait
Conditions
Brief summary
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.
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.
Interventions
No Intervention
Sponsors
Major Extremity Trauma Research Consortium
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use of the Mobility Toolkit during clinic | 12 months | Feasibility will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits. |
| Satisfaction of the Mobility Toolkit | 12 months | Satisfaction will be assessed through surveys of study participants and clinical staff to document time and burden of using MTK during clinic visits. |
| Gait Quality assessed with Mobility Tooklkit | 12 months | 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. |
| Gait Quality assessed by performance tests | Change in gate from measured at 3, 6 & 12 months | 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. |
| Physical Function | Change in physical function measured at 3, 6, & 12 months | 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. |
| Pain Score | Change in pain score measured at 3, 6, & 12 months | 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. |
| Number of patient complications resulting from injury | 12 months | Injury related complications such as infection, non-union, and hardware failure will be captured prospectively the year following treatment. |
Countries
United States
Outcome results
None listed