Status:
WITHDRAWN
BFRT vs Standard PT After Total Knee Arthroplasty
Lead Sponsor:
Norton Healthcare
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the pote...
Detailed Description
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the pote...
Eligibility Criteria
Inclusion
- Status post primary TKA and cleared by surgeon for Physical Therapy.
- Ages 50-79 years old
- Able to participate fully in PT
- Primary cruciate retaining or posterior stabilized TKA.
- Knee Range of Motion of surgical extremity is a minimum of 5° on full extension to 90° on full flexion
- •
Exclusion
- Unable to consent for study participation
- Unable to participate in preoperative testing
- Any ligamentous or osseous reconstruction at time of surgery that limits weight bearing
- History of Deep Vein Thrombosis
- Injury or recent procedure to uninvolved extremity within 6 months
- History of endothelial dysfunction
- History of Peripheral Vascular Disease including varicose veins
- Easy bruisability
- TKA is revision
- History of surgical wound complication on involved extremity
- History of stroke
- History of dementia
- History of neuromuscular disorder
- History of Chronic Obstructive Pulmonary Disease
- History of diabetes mellitus with neuropathy
- History of previous intra-articular fracture of involved extremity causing surgical fixation
- History of sickle cell trait/disease
- Previous participation in BFRT
- Any surgical procedure affecting their ability to complete all PT sessions or testing.
- History of functionally limiting arthritis in non-surgical Lower Extremity
- Prior contralateral Total Knee Arthroplasty
- Prior Total Hip Arthroplasty
- Positive pregnancy test
- Enrollment into another clinical research trial
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04366336
Start Date
February 18 2021
End Date
December 29 2021
Last Update
March 7 2022
Active Locations (1)
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1
Norton Healthcare
Louisville, Kentucky, United States, 40202