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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03562364
Other study ID # W81XWH-16-2-0060 AlterG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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