RECRUITING

Journey 2 Multi Center Kinematic Study

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Conditions

Total Knee Arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2021-05-15
Study Completion:2024-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05107414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients in the age range of 18 years to 85 years (both inclusive)
  2. 2. Patients who have a BMI less than 35
  3. 3. Patients who do not have previous surgery on the implanted knee that might restrict their movement
  4. 4. Patient who are at least 6 months post-operative
  5. 5. Patients who do not experience any pain or other post-operative complications
  6. 6. Patients who have a stable TKA and can perform a deep knee bend activity
  7. 7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
  8. 8. Subjects will have a Journey II knee system
  1. 1. 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.
  2. 2. Patients who have currently enrolled in a fluoroscopic study within the past year.
  3. 3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
  4. 4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
  5. 5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
  6. 6. Subjects who are unable to perform a deep knee bend.
  7. 7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
  8. 8. Subjects without the required type of knee implant.

Contacts and Locations

Study Contact

Michael LaCour, PhD
CONTACT
(865) 974-2093
mlacour@utk.edu
Richard Komistek, PhD
CONTACT
rkomiste@utk.edu

Study Locations (Sites)

University of Tennessee
Knoxville, Tennessee, 37996
United States

Collaborators and Investigators

Sponsor: The University of Tennessee, Knoxville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-15
Study Completion Date2024-12-15

Study Record Updates

Study Start Date2021-05-15
Study Completion Date2024-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty