Knee Osteoarthritis Clinical Trial
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
NCT number | NCT04612036 |
Other study ID # | WIRB20203268 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 22, 2020 |
Est. completion date | May 16, 2022 |
Verified date | February 2023 |
Source | The University of Tennessee, Knoxville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 16, 2022 |
Est. primary completion date | May 16, 2022 |
Accepts healthy volunteers | No |
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, either the BCS or XR, 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Tennessee | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
The University of Tennessee, Knoxville |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medial AP Translations, in mm | 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. | At least 6 months postoperative | |
Primary | Lateral AP Translations, in mm | 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. | At least 6 months postoperative | |
Primary | Maximum Flexion, in Degrees | 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. | At least 6 months postoperative | |
Primary | Axial Rotation, in Degrees | 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. | At least 6 months postoperative |
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