Blood Flow Restriction Training Following Total Knee Arthroplasty
- Conditions
- Total Knee ArthroplastyOsteoarthritis
- Registration Number
- NCT02763488
- Lead Sponsor
- San Antonio Military Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method quadriceps strength baseline up to 2 years post operative quadriceps strength via dynamometer
- Secondary Outcome Measures
Name Time Method Patient reported outcome 1: KOOS baseline up to 2 years post operative Patient reported measure of subject pain and function
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
Physical Outcome measure 2: Sit to stand test baseline up to 2 years post operative Validated functional outcome evaluating lower extremity 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
Trial Locations
- Locations (1)
San Antonio Military Medical Center
🇺🇸Ft Sam Houston, Texas, United States
San Antonio Military Medical Center🇺🇸Ft Sam Houston, Texas, United States