Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

July 14, 2017 updated by: Orthosensor, Inc.
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Recruiting
        • Holy Cross Hospital, Orthopedic Institute
        • Contact:
          • William Leone, MD
          • Phone Number: 954-489-4575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are candidates for revision TKA and meet all inclusion and no exclusion will be offered study participation without regard to race, sex, economic status, or religious belief.

Description

Inclusion Criteria:

  • Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure
  • Include Male and Female subjects
  • Include subjects 18 years and older
  • Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation
  • Patients able to understand study intent, and agree to study participation
  • Patients must be previously implanted with the following cruciate-retaining (CR) or posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.

Exclusion Criteria:

  • No prior revision surgery on operative side
  • Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
  • Culture positive aspiration indicating infection of the joint
  • ASA class > III
  • History of drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Partial Revision
A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component.
Procedure: VERASENSE
Sensor-Assisted Revision TKA
Other Names:
  • Sensor-Assisted TKA
Total Revision
A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner).
Procedure: VERASENSE
Sensor-Assisted Revision TKA
Other Names:
  • Sensor-Assisted TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define Revision Type and Primary Cause
Time Frame: Change from Surgical Outcome at 12-months.
The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.
Change from Surgical Outcome at 12-months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: Change from Baseline at 12-months
This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated.
Change from Baseline at 12-months
Veterans Rand 12-Item Health Survey
Time Frame: Change from Baseline at 12-months
This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health
Change from Baseline at 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthosensor, Inc.

Investigators

  • Principal Investigator: William Leone, MD, Holy Cross Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Revision TKA Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on VERASENSE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe