Blood Flow Restriction Training Following Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Blood Flow Restriction Training Following Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02763488
• Other study ID #: C.2016.109
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 2, 2016
• Last updated: June 14, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: San Antonio Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Device:
• DelfiPTS tourniquet system

Other:
• Standard physical therapy

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center	Ft Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quadriceps strength	quadriceps strength via dynamometer	baseline up to 2 years post operative	No
Secondary	Patient reported outcome 1: KOOS	Patient reported measure of subject pain and function	baseline up to 2 years post operative	No
Secondary	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	No
Secondary	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	No
Secondary	Patient reported outcome 4: Pain Visual analog score	Patient pain rating	baseline up to 2 years post operative	No
Secondary	Physical Outcome measure 1: Four square step test	Validated functional outcome evaluating lower extremity function	baseline up to 2 years post operative	No
Secondary	Physical Outcome measure 2: Sit to stand test	Validated functional outcome evaluating lower extremity function	baseline up to 2 years post operative	No
Secondary	Physical Outcome measure 3: 6 minute walk test	Validated functional outcome evaluating lower extremity function	baseline up to 2 years post operative	No
Secondary	Physical Outcome measure 4: Timed up and go test	Validated functional outcome evaluating lower extremity function	baseline up to 2 years post operative	No
Secondary	Physical Outcome measure 5: Timed stair ascent	Validated functional outcome evaluating lower extremity function	baseline up to 2 years post operative	No