Distal Femur FractureMWeSTNCT03864367
Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture
An observational study of Distal Femur Fracture, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Distal Femur Fracture
- What is being tested?
- Device - Prism Medical FGA-700 Bariatric Floor Lift
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 5 Jan 2021
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is anyone 55 years of age and older with a distal femur fracture.
Who may be able to join
- 55 and older
- distal femur fracture
- able to walk prior to fracture
Who cannot join
- patients unable to walk without any assistive devices post-injury
- patients too medically unstable to participate in physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes.
The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.
Read the detailed description
The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.
- Conditions
- Distal Femur Fracture
- Being tested
- Device - Prism Medical FGA-700 Bariatric Floor Lift
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device - Prism Medical FGA-700 Bariatric Floor LiftDevice
This group will be using a Mobile Weight-Support Therapy (MWeST) device (the Prism Medical FGA-700 Bariatric Floor Lift) to determine if it improves mobilization of older patients with traumas of their legs.
| Study group | Role | What they receive |
|---|---|---|
| Device | This group will use the MWeST lift device along with regular physical therapy. The lift device is the Prism Medical FGA-700 Bariatric Floor Lift including a sling to assist in walking. Receives: Device: Device - Prism Medical FGA-700 Bariatric Floor Lift | |
| Control | This group will only receive regular physical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking with device
Determining if the Mobile Weight-Support device helps improve mobility after injury compared to walking without device.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start28 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completion5 Jan 2021
Why it stopped: PI decided to end the study
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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANNA N MILLER, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864367
- Sponsor's protocol ID
- 201805050
- Acronym
- MWeST
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2019
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a single site study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture
- ClinicalTrials.gov ID
- NCT03864367
- Acronym / sponsor ID
- MWeST / 201805050
- Conditions
- Distal Femur Fracture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to end the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 6 Mar 2019 (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.
This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes.
The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.
Detailed description
The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | – | Device: Device - Prism Medical FGA-700 Bariatric Floor LiftThis group will use the MWeST lift device along with regular physical therapy. The lift device is the Prism Medical FGA-700 Bariatric Floor Lift including a sling to assist in walking. |
| Control | – | –This group will only receive regular physical therapy. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is anyone 55 years of age and older with a distal femur fracture.
Key inclusion criteria (3 listed)
- 55 and older
- distal femur fracture
- able to walk prior to fracture
Key exclusion criteria (2 listed)
- patients unable to walk without any assistive devices post-injury
- patients too medically unstable to participate in physical therapy
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 |
|---|---|---|
| Device - Prism Medical FGA-700 Bariatric Floor LiftThis group will be using a Mobile Weight-Support Therapy (MWeST) device (the Prism Medical FGA-700 Bariatric Floor Lift) to determine if it improves mobilization of older patients with traumas of their legs. | Device | Device |
Primary outcome
Walking with device
Time frame: 1 year
Determining if the Mobile Weight-Support device helps improve mobility after injury compared to walking without device.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No. This is a single site study.
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Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
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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.
ANNA N MILLER, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Femur Fracture, run by Washington University School of Medicine at 1 site 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Walking with device (time frame: 1 year). 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 7 Jan 2021.