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Blood Flow Restriction Training Following Total Knee Arthroplasty

Primary Purpose

Total Knee Arthroplasty, Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DelfiPTS tourniquet system
Standard physical therapy
Sponsored by
San Antonio Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Antonio Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard physical therapy

Blood flow restriction

Arm Description

These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol

These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy

Outcomes

Primary Outcome Measures

quadriceps strength
quadriceps strength via dynamometer

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2016
Last Updated
June 14, 2016
Sponsor
San Antonio Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02763488
Brief Title
Blood Flow Restriction Training Following Total Knee Arthroplasty
Official Title
Blood Flow Restriction Training Following Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Antonio Military Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Osteoarthritis
Keywords
blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard physical therapy
Arm Type
Active Comparator
Arm Description
These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol
Arm Title
Blood flow restriction
Arm Type
Experimental
Arm Description
These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy
Intervention Type
Device
Intervention Name(s)
DelfiPTS tourniquet system
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Primary Outcome Measure Information:
Title
quadriceps strength
Description
quadriceps strength via dynamometer
Time Frame
baseline up to 2 years post operative
Secondary Outcome Measure Information:
Title
Patient reported outcome 1: KOOS
Description
Patient reported measure of subject pain and function
Time Frame
baseline up to 2 years post operative
Title
Patient reported outcome 2: PROMIS Global Health
Description
PROMIS Global Health is a global measure of mental and physical health
Time Frame
baseline up to 2 years post operative
Title
Patient reported outcome 3: Promis-29
Description
NIH validated patient reported outcome measure evaluating multiple mental and physical domains
Time Frame
baseline up to 2 years post operative
Title
Patient reported outcome 4: Pain Visual analog score
Description
Patient pain rating
Time Frame
baseline up to 2 years post operative
Title
Physical Outcome measure 1: Four square step test
Description
Validated functional outcome evaluating lower extremity function
Time Frame
baseline up to 2 years post operative
Title
Physical Outcome measure 2: Sit to stand test
Description
Validated functional outcome evaluating lower extremity function
Time Frame
baseline up to 2 years post operative
Title
Physical Outcome measure 3: 6 minute walk test
Description
Validated functional outcome evaluating lower extremity function
Time Frame
baseline up to 2 years post operative
Title
Physical Outcome measure 4: Timed up and go test
Description
Validated functional outcome evaluating lower extremity function
Time Frame
baseline up to 2 years post operative
Title
Physical Outcome measure 5: Timed stair ascent
Description
Validated functional outcome evaluating lower extremity function
Time Frame
baseline up to 2 years post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Tennent, MD
Organizational Affiliation
San Antonio Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Antonio Military Medical Center
City
Ft Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restriction Training Following Total Knee Arthroplasty

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