N/A
N=60
In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Knee Osteoarthritis · Total Knee Arthroplasty · Knee
Bottom Line
View on ClinicalTrials.gov: NCT04612036 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Medial AP Translations, in mm — -6.9; -0.2; -4.4 millimeters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Journey II Bi-Cruciate Stabilized TKA (Device); Journey II Cruciate Retaining TKA (Device); Journey II Bi-Cruciate Retaining TKA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medial AP Translations, in mm |
-6.9; -0.2; -4.4 | — |
| PRIMARY Lateral AP Translations, in mm |
-12.5; -4.7; -9.4 | — |
| PRIMARY Maximum Flexion, in Degrees |
108; 121; 105 | — |
| PRIMARY Axial Rotation, in Degrees |
7.1; 5.6; 6.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04612036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.