Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03023410
• Other study ID #: Revision TKA Study
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2017
• Last updated: July 14, 2017
• Start date: July 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2017
• Source: Orthosensor, Inc.
• Contact: Christopher R Anderson, MS, MBA
• Phone: 954-577-7770
• Email: canderson[@]orthosensor.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• VERASENSE
Sensor-Assisted Revision TKA

Locations

Country	Name	City	State
United States	Holy Cross Hospital, Orthopedic Institute	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define Revision Type and Primary Cause	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	Knee Society Score	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
Secondary	Veterans Rand 12-Item Health Survey	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