Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries

Study Overview
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Brief Summary
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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.

Official Title
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Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)

Conditions
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Distal Femur Fracture, Tibial Plateau Fracture, Distal Tibia Fracture, Pilon Fracture

Intervention / Treatment
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* Other: AlterG anti-gravity treadmill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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)<br>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 | Other: AlterG anti-gravity treadmill<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | 6 month following study injury | 
| Ankle Osteoarthritis Score (AOS) | 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 | 6 month following study injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-gravity