Blood Flow Restriction Training Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Blood Flow Restriction Training Following Primary Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty, Osteoarthritis

Intervention / Treatment
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* Device: DelfiPTS tourniquet system
* Other: Standard physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard physical therapy<br>These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol | Other: Standard physical therapy<br> <br> |
| Experimental: Blood flow restriction<br>These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy | Device: DelfiPTS tourniquet system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quadriceps strength | quadriceps strength via dynamometer | baseline up to 2 years post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome 1: KOOS | Patient reported measure of subject pain and function | baseline up to 2 years post operative | 
| Patient reported outcome 2: PROMIS Global Health | PROMIS Global Health is a global measure of mental and physical health | baseline up to 2 years post operative | 
| Patient reported outcome 3: Promis-29 | NIH validated patient reported outcome measure evaluating multiple mental and physical domains | baseline up to 2 years post operative | 
| Patient reported outcome 4: Pain Visual analog score | Patient pain rating | baseline up to 2 years post operative | 
| Physical Outcome measure 1: Four square step test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative | 
| Physical Outcome measure 2: Sit to stand test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative | 
| Physical Outcome measure 3: 6 minute walk test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative | 
| Physical Outcome measure 4: Timed up and go test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative | 
| Physical Outcome measure 5: Timed stair ascent | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation