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Completed

NCT Number: NCT04612036

In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Tennessee

Knoxville, Tennessee, 37996, United States

About this study

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in the age range of 18 years to 85 years (both inclusive)
  • Patients who have a BMI less than 35
  • Patients who do not have previous surgery on the implanted knee that might restrict their movement
  • Patient who are at least 6 months post-operative
  • Patients who do not experience any pain or other post-operative complications
  • Patients who have a stable TKA and can perform a deep knee bend activity
  • Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
  • Subjects will have a Journey II, either the BCS or XR, knee system

Exclusion criteria

  • Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
  • Patients who have currently enrolled in a fluoroscopic study within the past year.
  • Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
  • Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
  • Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
  • Subjects who are unable to perform a deep knee bend.
  • Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
  • Subjects without the required type of knee implant.

Treatment and study plan

Journey II Bi-Cruciate Stabilized TKA

Device

Total Knee Arthroplasty System

Journey II Cruciate Retaining TKA

Device

Total Knee Arthroplasty System

Journey II Bi-Cruciate Retaining TKA

Device

Total Knee Arthroplasty System

Primary outcomes

  1. Medial AP Translations, in mm

    Time frame: At least 6 months postoperative

    Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.

  2. Lateral AP Translations, in mm

    Time frame: At least 6 months postoperative

    Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.

  3. Maximum Flexion, in Degrees

    Time frame: At least 6 months postoperative

    Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.

  4. Axial Rotation, in Degrees

    Time frame: At least 6 months postoperative

    Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Official study title

Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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