Status:
COMPLETED
Combined NMES and BFR Training After TKA
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Delphi Medical Innovations Inc.
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of this feasibility study is to determine the initial efficacy of early combined Neuromuscular Electrical Stimulation (NMES) and Blood Flow Restriction (BFR) in addition to standard rehabi...
Detailed Description
It's estimated that almost 3.5 million Total Knee Arthroplasties (TKA) will be performed annually by 2030. Despite initiating rehabilitation within 48 hours of surgery, up to a 60% strength loss is no...
Eligibility Criteria
Inclusion
- Scheduled to undergo primary unilateral total knee arthroplasty secondary to end-stage osteoarthritis
Exclusion
- BMI \> 40 kgm2
- Current smoker or history of drug abuse
- Comorbid conditions that substantially limit physical function or would interfere with the participant's ability to successfully complete rehabilitation (e.g. neurologic, vascular, cardiac problems, or ongoing medical treatments)
- Unstable orthopedic conditions that limit function
- Uncontrolled diabetes (hemoglobin A1c level \> 8.0)
- Pregnancy
- Preoperative ROM less than 10-120 degrees
- Demand cardiac pacemaker or unstable arrhythmia
- Prior history of DVT/PE
- Thrombophilia or other clotting disorders
- Sickle cell trait/anemia
- History of peripheral vascular disease
- Patient report of easy bruising
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04347343
Start Date
November 22 2019
End Date
February 3 2022
Last Update
March 7 2022
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045