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

NCT02286739 | Terminated Results

• 1 other identifier: 102
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoarthritis

Keywords

Total Knee Arthroplasty; Rotational Alignment; Intraoperative Sensors; Patient Outcomes; Soft Tissue Balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Knee Society Knee Scoring System

  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).

  Pre-operative, 6 weeks, 6 months, 1 year and 2 years

• Forgotten Joint Score (FJS)

  6 weeks, 6 months, 1 year, 2 years

Study Arms (2)

Group A TKA without VERASENSE

SHAM COMPARATOR

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"

Group B TKA with VERASENSE

ACTIVE COMPARATOR

Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.

Device: TKA with "Verasense"

Interventions

TKA with "Verasense" 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.

Group B TKA with VERASENSE

TKA without "Verasense" PROCEDURE

TKA will be performed manually without the use of Verasense

Group A TKA without VERASENSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthosensor, Inc.: lead

Study Sites (6)

The Cleveland Clinic Foundation

Weston, Florida, 33331, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Illinois Bone & Joint Institute

Morton Grove, Illinois, 60053, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The evaluation of tibiofemoral rotational alignment using intraoperative sensing which was highlighted in the study title, was identified off-label. Any data which should have been evaluated off-label are not included in the study results. Since the study has already ended at time point of data posting, the study title was not subsequently updated.

Results Point of Contact

• Title: Kevin Barga
• Organization: Stryker

kevin.barga@stryker.com

201 831 5073

Study Officials

• Greg Golladay, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 10, 2014
• Study Start: April 1, 2015
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-08

Locations

US (6)