Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture

NCT03864367 | Withdrawn FDA Device

• 1 other identifier: 201805050
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Walking with device

  Determining if the Mobile Weight-Support device helps improve mobility after injury compared to walking without device.

  1 year

Study Arms (2)

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.

Device: Device - Prism Medical FGA-700 Bariatric Floor Lift

Control

This group will only receive regular physical therapy.

Interventions

Device - Prism Medical FGA-700 Bariatric Floor Lift DEVICE

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.

Device

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is anyone 55 years of age and older with a distal femur fracture.

You may qualify if:

• and older
• distal femur fracture
• able to walk prior to fracture

You may not qualify if:

• patients unable to walk without any assistive devices post-injury
• patients too medically unstable to participate in physical therapy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• ANNA N MILLER, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: March 6, 2019
• Study Start: January 28, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 5, 2021
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)