Clinical trial NCT02763488: Blood Flow Restriction Training Following Total Knee Arthroplasty
Official title: Blood Flow Restriction Training Following Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Osteoarthritis
Keywords: blood flow restriction training
occlusion training
total knee arthroplasty
post-operative rehabilitation
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2016-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: quadriceps strength
timeFrame: baseline up to 2 years post operative
Secondary outcomes:
measure: Patient reported outcome 1: KOOS
timeFrame: baseline up to 2 years post operative
measure: Patient reported outcome 2: PROMIS Global Health
timeFrame: baseline up to 2 years post operative
measure: Patient reported outcome 3: Promis-29
timeFrame: baseline up to 2 years post operative
measure: Patient reported outcome 4: Pain Visual analog score
timeFrame: baseline up to 2 years post operative
measure: Physical Outcome measure 1: Four square step test
timeFrame: baseline up to 2 years post operative
measure: Physical Outcome measure 2: Sit to stand test
timeFrame: baseline up to 2 years post operative
measure: Physical Outcome measure 3: 6 minute walk test
timeFrame: baseline up to 2 years post operative
measure: Physical Outcome measure 4: Timed up and go test
timeFrame: baseline up to 2 years post operative
measure: Physical Outcome measure 5: Timed stair ascent
timeFrame: baseline up to 2 years post operative
Other outcomes:
Locations:
city: Ft Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: San Antonio Military Medical Center
name: David J Tennent, MD
role: PRINCIPAL_INVESTIGATOR
References: