Distal Femur Fracture Clinical Trial
— AlterGOfficial title:
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
Verified date | December 2023 |
Source | Major Extremity Trauma Research Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | University of Virginia | Charlottesville | Virginia |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | University of Texas Health Science Center - Houston | Houston | Texas |
United States | University of Kentucky | Lexington | Kentucky |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
United States | San Antonio Military Medical Center (SAMMC) | San Antonio | Texas |
United States | Naval Medical Center San Diego | San Diego | California |
United States | University of California at San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Major Extremity Trauma Research Consortium | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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