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

Overview

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.

Full Title of Study: “Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 30, 2022

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • The Knee Injury and Osteoarthritis Outcome Score (KOOS)
    • Time Frame: 6 month following study injury
    • 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.
  • Ankle Osteoarthritis Score (AOS)
    • Time Frame: 6 month following study injury
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Major Extremity Trauma Research Consortium
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel Stinner, MD, Principal Investigator, Vanderbilt University Medical Center

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