Blood Flow Restriction Training Following Total Knee Arthroplasty

Blood Flow Restriction Training Following Primary Total Knee Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Total Knee Arthroplasty
• Intervention / Treatment: Other: Standard physical therapy; Device: DelfiPTS tourniquet system

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Ft Sam Houston, Texas, United States, 78234
      • San Antonio Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard physical therapy; These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol	Other: Standard physical therapy
Experimental: Blood flow restriction; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: San Antonio Military Medical Center
• Investigators: Principal Investigator: David J Tennent, MD, San Antonio Military Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: total knee arthroplasty; blood flow restriction training; occlusion training; post-operative rehabilitation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: C.2016.109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO