Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
AlterG
1 other identifier
interventional
81
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedDecember 22, 2023
December 1, 2023
3.7 years
May 15, 2018
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Standard of Care
NO INTERVENTIONThe 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.
Early Advanced Weight Bearing (EAWB)
EXPERIMENTALThe 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
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Naval Medical Center San Diego
San Diego, California, 92134, United States
University of California at San Francisco
San Francisco, California, 94110, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Texas Health Science Center - Houston
Houston, Texas, 77030, United States
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Stinner, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
June 19, 2018
Study Start
February 25, 2019
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
December 22, 2023
Record last verified: 2023-12