Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries (AlterG)

Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)

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.

Study Overview

• Status: Completed
• Conditions: Pilon Fracture; Tibial Plateau Fracture; Distal Femur Fracture; Distal Tibia Fracture
• Intervention / Treatment: Other: AlterG anti-gravity treadmill

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
    • San Francisco, California, United States, 94110
      • University of California at San Francisco
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center - Houston
    • San Antonio, Texas, United States, 78234
      • San Antonio Military Medical Center (SAMMC)
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcomes Measurement Information Systems (PROMIS) Physical Function	assessing physical function through a grading scale of activities of daily living	6 month following study injury
Fracture healing	assessed by clinical and radiographic examinations following treatment	12 month following study injury
Complications	all limb related complications will be categorized in relation to the study injury	12 month following study injury
Patient satisfaction	A set of questions to measure the satisfactory level with therapy received	12 month following study injury

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Daniel Stinner, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: anti-gravity
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Knee Fractures; Femoral Fractures; Fractures, Bone; Tibial Fractures; Femoral Fractures, Distal; Tibial Plateau Fractures
• Other Study ID Numbers: W81XWH-16-2-0060 AlterG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No