Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

Study Overview
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Brief Summary
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The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.

Detailed Description
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Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.

Official Title
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Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: TKA with Verasense
* Procedure: TKA without Verasense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™ Subject must be diagnosed with one or more of the following conditions osteoarthritis rheumatoid or other inflammatory arthritis post-traumatic arthritis Subject is likely to be available for all study visits Subject is able and willing to sign the informed consent and follow study procedures Exclusion Criteria: Prior Total Knee Arthroplasty Avascular Necrosis Any knee surgery other than meniscectomy (can be arthroscopic or open) Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures Ipsilateral foot/ankle and hip arthritis Range of motion less than 90°, flexion contracture greater than 20° Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group A TKA without VERASENSE<br>will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. | Procedure: TKA without Verasense<br>* TKA will be performed manually without the use of Verasense<br>|
| Active Comparator: Group B TKA with VERASENSE<br>will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. | Device: TKA with Verasense<br>* VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Pain and Functional Scoring |  | Changes from baseline at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Knee Pain Evaluation |  | Changes from baseline at 24 months | 
| EQ5D |  | Changes from baseline at 24 months | 
| Forgotten Joint Score |  | Changes from baseline at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance