Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)

Not Applicable

Terminated

Conditions: Osteoarthritis

Interventions: Device: TKA with "Verasense"
Procedure: TKA without "Verasense"

Registration Number: NCT02286739

Lead Sponsor: Orthosensor, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 500

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 anterior cruciate ligament (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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B TKA with VERASENSE	TKA with "Verasense"	Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
Group A TKA without VERASENSE	TKA without "Verasense"	Patients who undergo primary posterior cruciate ligament (PCL)-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty	Intra-operative with trial implants in place and after completing all surgical corrections.	Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.

Secondary Outcome Measures

Name	Time	Method
Forgotten Joint Score (FJS)	6 weeks, 6 months, 1 year, 2 years	The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Knee Society Knee Scoring System	pre-operative, 6 weeks, 6 months, 1 year, 2 years	"Patient Satisfaction" is a three-question 40-point scale and has a score of 0 (not satisfied) to 40 (very satisfied) that is collected preoperatively and at each follow-up visit. "Patient Expectations" is a five-question fifteen-point scale and has a score of 0 (low expectation) to 15 (high expectation) that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function. The "functional score" is composed of four subgroups (Walking and standing, standard activities, advanced activities, discretionary activities) and has a score of 0 (poor) to 100 (excellent).
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).	Pre-operative, 6 weeks, 6 months, 1 year and 2 years	The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The scores range from -0.59 (worst possible health state) to 1 (best possible health state).

Trial Locations

Locations (5): Illinois Bone & Joint Institute
🇺🇸
Morton Grove, Illinois, United States
NYU Hospital for Joint Diseases
🇺🇸
New York, New York, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States