Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

OrthoSensor

Status: Terminated

Conditions: Knee Osteoarthritis

Treatments: Procedure: VERASENSE

Study type: Observational

Funder types: Industry

Identifiers

NCT03023410

Revision TKA Study

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 2 patient groups

Partial Revision

Description:

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.

Treatment:

Procedure: VERASENSE

Total Revision

Description:

A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner).

Treatment:

Procedure: VERASENSE