Clinical trial NCT03023410: Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
Official title: Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: Revision TKA
Instability
Stiffness
Aseptic Loosening
Polyethylene Wear
Malrotation
Soft Tissue Imbalance
Lead sponsor: Orthosensor, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cause of Early TKA Revision
timeFrame: 12-months
Secondary outcomes:
measure: Knee Society Score
timeFrame: 12 months
measure: Veterans Rand 12-Item Health Survey
timeFrame: Change from Baseline at 12-months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital, Orthopedic Institute
state: Florida
Study officials:
affiliation: Holy Cross Hospital
name: William Leone, MD
role: PRINCIPAL_INVESTIGATOR
References: