Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
NCT ID: NCT03562364
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2019-02-25
2022-10-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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
AlterG anti-gravity treadmill
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
Interventions
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AlterG anti-gravity treadmill
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Daniel Stinner, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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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
Countries
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Other Identifiers
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W81XWH-16-2-0060 AlterG
Identifier Type: -
Identifier Source: org_study_id