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

NCT ID: NCT02286739

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2020-05-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

TKA without "Verasense"

Intervention Type: PROCEDURE

TKA will be performed manually without the use of Verasense

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.

Group Type: ACTIVE_COMPARATOR

TKA with "Verasense"

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

TKA without "Verasense"

TKA will be performed manually without the use of Verasense

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthosensor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg Golladay, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

The Cleveland Clinic Foundation

Weston, Florida, United States

Emory University

Atlanta, Georgia, United States

Illinois Bone & Joint Institute

Morton Grove, Illinois, United States

NYU Hospital for Joint Diseases

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

102

Identifier Type: -

Identifier Source: org_study_id