Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
Purpose
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.
Conditions
- Distal Femur Fracture
- Tibial Plateau Fracture
- Distal Tibia Fracture
- Pilon Fracture
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
No Intervention Standard of Care |
The standard of care group will remain non-weight bearing for 10-12 weeks following definitive fixation and receive physical therapy in accordance with standard practice at the treating center. |
|
Experimental Early Advanced Weight Bearing (EAWB) |
The Early Advanced Weight Bearing (EAWB) group will receive early weight-bearing treatment using the antigravity AlterG treadmill. These sessions will begin 14-28 days following definitive fixation and last for a total of 10 weeks |
|
Recruiting Locations
More Details
- NCT ID
- NCT03562364
- Status
- Completed
- Sponsor
- Major Extremity Trauma Research Consortium