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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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. | |
| Early Advanced Weight Bearing (EAWB) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlterG anti-gravity treadmill | Other | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Stinner, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| University of California at San Francisco |
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| 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 |
| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| D000092463 | Tibial Plateau Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D000092443 | Knee Fractures |
| D013978 | Tibial Fractures |
| D007718 | Knee Injuries |
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