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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03562364

Run by

Major Extremity Trauma Research Consortium

People needed

81

Starts

2019-02-25

Expected to finish

2022-10-30

Last updated by the study team

2023-12-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• University of Kentucky — Lexington, Kentucky, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Texas Health Science Center - Houston — Houston, Texas, United States
• San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States

Full record on ClinicalTrials.gov

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