Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation
Brief summary
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.
Detailed description
Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.
Interventions
DEVICEDelfiPTS tourniquet system
OTHERStandard physical therapy
Sponsors
San Antonio Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy * Males and females 50-79 years of age * Ability to consent to study enrollment * Able to participate fully in physical therapy * Tricare Beneficiary * Implant restricted: primary cruciate retaining or posterior stabilized total knee arthroplasty * Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion\*\* * only screened at secondary screening
Exclusion criteria
* Unable to consent for study participation * Unable to participate in preoperative testing * Any ligamentous or bony reconstruction performed at time of surgery that limits weight bearing or rehabilitation protocol * History of deep venous thrombosis * Injury or recent procedure to contralateral extremity within past 6 months * History of endothelial dysfunction * History of Peripheral Vascular Disease * Patient endorsement of easy bruising * Revision Total Knee Arthroplasty * History of Surgical wound complication on involved extremity * History of Cerebral Vascular Event * History of Dementia * History of Neuromuscular disorder * History of Chronic Obstructive Pulmonary Disease requiring oxygen supplementation or limiting participants ability to perform therapy and/or testing * History of previous intra-articular fracture of surgical extremity requiring open reduction and internal fixation or external fixation * History of Sickle cell trait and/or disease * Previously participated in blood flow restriction training interventions * Planned or unplanned additional surgical procedures affecting their ability to complete all session of physical therapy or testing during the following 6 months from their primary intervention * Patient reported history of functionally limiting arthritis in non-surgical lower extremity or ipsilateral hip or ankle * History or previous contralateral total knee arthroplasty * Any history of previous total hip arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quadriceps strength | baseline up to 2 years post operative | quadriceps strength via dynamometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome 2: PROMIS Global Health | baseline up to 2 years post operative | PROMIS Global Health is a global measure of mental and physical health |
| Patient reported outcome 3: Promis-29 | baseline up to 2 years post operative | NIH validated patient reported outcome measure evaluating multiple mental and physical domains |
| Patient reported outcome 4: Pain Visual analog score | baseline up to 2 years post operative | Patient pain rating |
| Physical Outcome measure 1: Four square step test | baseline up to 2 years post operative | Validated functional outcome evaluating lower extremity function |
| Patient reported outcome 1: KOOS | baseline up to 2 years post operative | Patient reported measure of subject pain and function |
| Physical Outcome measure 3: 6 minute walk test | baseline up to 2 years post operative | Validated functional outcome evaluating lower extremity function |
| Physical Outcome measure 4: Timed up and go test | baseline up to 2 years post operative | Validated functional outcome evaluating lower extremity function |
| Physical Outcome measure 5: Timed stair ascent | baseline up to 2 years post operative | Validated functional outcome evaluating lower extremity function |
| Physical Outcome measure 2: Sit to stand test | baseline up to 2 years post operative | Validated functional outcome evaluating lower extremity function |
Countries
United States
Outcome results
None listed