Blood Flow Restriction Training Following Total Knee Arthroplasty

NCT02763488 | Unknown

• 1 other identifier: C.2016.109
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Keywords

blood flow restriction training; occlusion training; total knee arthroplasty; post-operative rehabilitation

Outcome Measures

Primary Outcomes (1)

• quadriceps strength

  quadriceps strength via dynamometer

  baseline up to 2 years post operative

Secondary Outcomes (9)

• 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

• Patient reported outcome 4: Pain Visual analog score

  baseline up to 2 years post operative

• Physical Outcome measure 1: Four square step test

  baseline up to 2 years post operative

Study Arms (2)

Standard physical therapy

ACTIVE COMPARATOR

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

Other: Standard physical therapy

Blood flow restriction

EXPERIMENTAL

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

Interventions

DelfiPTS tourniquet system DEVICE

Blood flow restriction

Standard physical therapy OTHER

Standard physical therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

Study Sites (1)

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David J Tennent, MD

  San Antonio Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Resident

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2019
• Last Updated: June 16, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)