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

Distal Femur Fracture Clinical Trial

— AlterG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562364
• Other study ID #: W81XWH-16-2-0060 AlterG
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2023
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Femur Fracture
• Distal Tibia Fracture
• Femoral Fractures
• Fractures, Bone
• Pilon Fracture
• Tibial Fractures
• Tibial Plateau Fracture

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Texas Health Science Center - Houston	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	San Antonio Military Medical Center (SAMMC)	San Antonio	Texas
United States	Naval Medical Center San Diego	San Diego	California
United States	University of California at San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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