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

Not Applicable

Completed

• Conditions: Pilon Fracture; Distal Femur Fracture; Distal Tibia Fracture; Tibial Plateau Fracture
• Interventions: Other: AlterG anti-gravity treadmill

• Registration Number: NCT03562364
• Lead Sponsor: Major Extremity Trauma Research Consortium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Study Start: 2019-02-25
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Advanced Weight Bearing (EAWB)	AlterG anti-gravity treadmill	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

Primary Outcome Measures

Name	Time	Method
Ankle Osteoarthritis Score (AOS)	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
The Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.

Trial Locations

Locations (10)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Texas Health Science Center - Houston; 🇺🇸 Houston, Texas, United States

San Antonio Military Medical Center (SAMMC); 🇺🇸 San Antonio, Texas, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Naval Medical Center Portsmouth; 🇺🇸 Portsmouth, Virginia, United States