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

Primary Purpose

Distal Femur Fracture, Tibial Plateau Fracture, Distal Tibia Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AlterG anti-gravity treadmill
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fracture focused on measuring anti-gravity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Naval Medical Center San Diego
  • University of California at San Francisco
  • University of Kentucky
  • Walter Reed National Military Medical Center
  • Hennepin County Medical Center
  • University of Texas Health Science Center - Houston
  • San Antonio Military Medical Center (SAMMC)
  • University of Virginia
  • Inova Fairfax Hospital
  • Naval Medical Center Portsmouth

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Early Advanced Weight Bearing (EAWB)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
May 15, 2018
Last Updated
May 12, 2023
Sponsor
Major Extremity Trauma Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT03562364
Brief Title
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
Acronym
AlterG
Official Title
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Major Extremity Trauma Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fracture, Tibial Plateau Fracture, Distal Tibia Fracture, Pilon Fracture
Keywords
anti-gravity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Early Advanced Weight Bearing (EAWB)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
AlterG anti-gravity treadmill
Intervention Description
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 Outcome Measure Information:
Title
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
6 month following study injury
Title
Ankle Osteoarthritis Score (AOS)
Description
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
Time Frame
6 month following study injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Stinner, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Texas Health Science Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Medical Center (SAMMC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States

12. IPD Sharing Statement

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

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