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

Major Extremity Trauma Research Consortium

Status: Completed

Conditions: Gait

Treatments: Other: None- Observational Study

Study type: Observational

Funder types: Other

Identifiers

NCT04047030

W81XWH-18-1-0815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

244 participants in 2 patient groups

Injured Cohort

Description:

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.

Treatment:

Other: None- Observational Study

Non-Injured Volunteers

Description:

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.

Treatment:

Other: None- Observational Study