Blood Flow Restriction Training Following Total Knee Arthroplasty

S

San Antonio Military Medical Center

Status

Unknown

Conditions

Osteoarthritis
Total Knee Arthroplasty

Treatments

Device: DelfiPTS tourniquet system
Other: Standard physical therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02763488
C.2016.109

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Standard physical therapy
Active Comparator group
Description:
These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol
Treatment:
Other: Standard physical therapy
Blood flow restriction
Experimental group
Description:
These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy
Treatment:
Device: DelfiPTS tourniquet system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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