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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05107414
Other study ID # 20203268
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2021
Est. completion date December 15, 2024

Study information

Verified date May 2023
Source The University of Tennessee, Knoxville
Contact Michael LaCour, PhD
Phone (865) 974-2093
Email mlacour@utk.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Patients in the age range of 18 years to 85 years (both inclusive) 2. Patients who have a BMI less than 35 3. Patients who do not have previous surgery on the implanted knee that might restrict their movement 4. Patient who are at least 6 months post-operative 5. Patients who do not experience any pain or other post-operative complications 6. Patients who have a stable TKA and can perform a deep knee bend activity 7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms 8. Subjects will have a Journey II knee system Exclusion Criteria: 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. Patients who have currently enrolled in a fluoroscopic study within the past year. 3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims. 4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. 5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability 6. Subjects who are unable to perform a deep knee bend. 7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents. 8. Subjects without the required type of knee implant.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Knee Arthroplasty
Participants have previously undergone a total knee replacement surgery.

Locations

Country Name City State
United States University of Tennessee Knoxville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Femorotibial Medial Condylar Rollback The condylar rollback of the medial condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. Baseline, at time of observation
Primary Femorotibial Lateral Condylar Rollback The condylar rollback of the lateral condyle will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. Baseline, at time of observation
Primary Femorotibial Axial Rotation The femorotibial axial rotation will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. Baseline, at time of observation
Primary Femorotibial Weight Bearing Flexion The femorotibial weight bearing flexion will be observed at a single instance in time. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. Baseline, at time of observation
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