Distal Femur Fracture, Distal Tibia Fracture, Pilon Fracture, Tibial Plateau Fracture
Conditions
Keywords
anti-gravity
Brief summary
The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.
Interventions
The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment
Sponsors
United States Department of Defense
Major Extremity Trauma Research Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-55 * Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C) * Definitively treated with a plate * Ambulatory prior to injury * Able to participate in rehab starting 28 days after definitive fixation * Meets AlterG requirements (4'8- 6'4; 85-400lbs)
Exclusion criteria
* Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.) * Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility * Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device * Pregnancy * Unable to speak English * Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders). * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 month following study injury | The KOOS is a 42 item assessment that evaluates joint function by asking patients to rate their symptoms and concerns in 5 domains: pain, other symptoms, function in daily living (ADL), function in sport and recreation, and foot and ankle quality of life on a scale of 0-4. |
| Ankle Osteoarthritis Score (AOS) | 6 month following study injury | The AOS is an assessment that evaluates joint function by asking patients to rate their pain and disability while performing 18 different activities of daily living using a visual analogue scale |
Countries
United States
Outcome results
None listed