Distal Femur FractureAlterGNCT03562364
Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
A study testing AlterG anti-gravity treadmill in people with Distal Femur Fracture and Tibial Plateau Fracture, run by Major Extremity Trauma Research Consortium at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Distal Femur Fracture, Tibial Plateau Fracture, Distal Tibia Fracture
- What is being tested?
- AlterG anti-gravity treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Feb 2019to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Virginia
Charlottesville, Virginia, 22908
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Texas Health Science Center - Houston
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40506
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
Naval Medical Center San Diego
San Diego, California, 92134
University of California at San Francisco
San Francisco, California, 94110
About this study
Official title: Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
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.
- Being tested
- AlterG anti-gravity treadmill
- Keywords
- anti-gravity
- Medical subject headings
- Femoral Fractures, Distal, Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlterG anti-gravity treadmillOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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. |
| Early Advanced Weight Bearing (EAWB) | Experimental | 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 Receives: Other: AlterG anti-gravity treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month following study injury
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
Measured: 6 month following study injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start25 Feb 2019
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Daniel Stinner, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562364
- Sponsor's protocol ID
- W81XWH-16-2-0060 AlterG
- Acronym
- AlterG
- Status last verified
- Dec 2023
- First submitted
- 15 May 2018
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
- ClinicalTrials.gov ID
- NCT03562364
- Acronym / sponsor ID
- AlterG / W81XWH-16-2-0060 AlterG
- Keywords
- anti-gravity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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. |
| Early Advanced Weight Bearing (EAWB) | Experimental | Other: AlterG anti-gravity treadmillThe 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlterG anti-gravity treadmillThe AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment | Other | Early Advanced Weight Bearing (EAWB) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Stinner, MD principal investigator
Vanderbilt University Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlterG anti-gravity treadmill in people with Distal Femur Fracture and Tibial Plateau Fracture, run by Major Extremity Trauma Research Consortium at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 6 month following study injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.