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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: TKA without "Verasense"; Device: TKA with "Verasense"

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • The Cleveland Clinic Foundation
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Illinois Bone & Joint Institute
  • New York
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group A 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.	Procedure: TKA without "Verasense"; TKA will be performed manually without the use of Verasense
Active Comparator: Group B TKA with VERASENSE; Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.	Device: TKA with "Verasense"; 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 pre-market submission (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty	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.	Intra-operative with trial implants in place and after completing all surgical corrections.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Knee Scoring System	"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).	pre-operative, 6 weeks, 6 months, 1 year, 2 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).	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).	Pre-operative, 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score (FJS)	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.	6 weeks, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Orthosensor, Inc.
• Investigators: Principal Investigator: Greg Golladay, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimated): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Rotational Alignment; Intraoperative Sensors; Patient Outcomes; Soft Tissue Balance
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No