Clinical trial NCT03562364: Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
Official title: Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Femur Fracture
Tibial Plateau Fracture
Distal Tibia Fracture
Pilon Fracture
Keywords: anti-gravity
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-06-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 month following study injury
measure: Ankle Osteoarthritis Score (AOS)
timeFrame: 6 month following study injury
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center (SAMMC)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel Stinner, MD
role: PRINCIPAL_INVESTIGATOR
References: