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Clinical Trials/NCT02763488
NCT02763488
Unknown
Not Applicable

Blood Flow Restriction Training Following Primary Total Knee Arthroplasty

San Antonio Military Medical Center1 site in 1 country100 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
San Antonio Military Medical Center
Enrollment
100
Locations
1
Primary Endpoint
quadriceps strength
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Tennent

Orthopaedic Surgery Resident

San Antonio Military Medical Center

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

Outcomes

Primary Outcomes

quadriceps strength

Time Frame: baseline up to 2 years post operative

quadriceps strength via dynamometer

Secondary Outcomes

  • Patient reported outcome 4: Pain Visual analog score(baseline up to 2 years post operative)
  • Patient reported outcome 1: KOOS(baseline up to 2 years post operative)
  • Patient reported outcome 2: PROMIS Global Health(baseline up to 2 years post operative)
  • Patient reported outcome 3: Promis-29(baseline up to 2 years post operative)
  • Physical Outcome measure 1: Four square step test(baseline up to 2 years post operative)
  • Physical Outcome measure 2: Sit to stand test(baseline up to 2 years post operative)
  • Physical Outcome measure 3: 6 minute walk test(baseline up to 2 years post operative)
  • Physical Outcome measure 4: Timed up and go test(baseline up to 2 years post operative)
  • Physical Outcome measure 5: Timed stair ascent(baseline up to 2 years post operative)

Study Sites (1)

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