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

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.

Completed

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Key information

Conditions

Distal Femur Fracture Distal Tibia Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Knee Fractures Knee Injuries Leg Injuries Pilon Fracture Tibial Fractures Tibial Plateau Fracture Tibial Plateau Fractures Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Collaborators

United States Department of Defense

Registry information

Official study title

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

Acronym: AlterG

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Jun 19, 2018
Registry last updated: Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed