Blood Flow Restriction Training Following Total Knee Arthroplasty

NCT ID: NCT02763488

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard physical therapy

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

Group Type: ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

DelfiPTS tourniquet system

Intervention Type: DEVICE

Interventions

DelfiPTS tourniquet system

Intervention Type: DEVICE

Standard physical therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Antonio Military Medical Center

FED

Sponsor Role: lead

Responsible Party

David Tennent

Orthopaedic Surgery Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Tennent, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio Military Medical Center

Locations

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

C.2016.109

Identifier Type: -

Identifier Source: org_study_id