N/A
N=50
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
Arthroplasty, Replacement, Knee · Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03088748 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Lateral Kinematics Translations While Ascending Ramp — 0.1; -0.4 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Journey II posterior cruciate retaining total knee arthroplasty (Device); Journey II posterior bi-cruciate retaining total knee arthroplasty (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lateral Kinematics Translations While Ascending Ramp |
0.1; -0.4 | — |
| PRIMARY Medial Kinematics Translations While Ascending Ramp |
-1.8; -2.0 | — |
| PRIMARY Axial Rotation While Ascending Ramp |
-2.6; -2.0 | — |
| PRIMARY Lateral Kinematics Translations While Descending Ramp |
0.1; -6.3 | — |
| PRIMARY Medial Kinematics Translations While Descending Ramp |
-1.0; -3.2 | — |
| PRIMARY Axial Rotation While Descending Ramp |
-1.2; 3.7 | — |
| PRIMARY Lateral Kinematics Translations During Deep Knee Bend |
-3.7; -9.4 | — |
| PRIMARY Medial Kinematics Translations During Deep Knee Bend |
1.0; -4.4 | — |
| PRIMARY Axial Rotation During Deep Knee Bend |
5.9; 6.0 | — |
| PRIMARY Maximum Flexion During Deep Knee Bend |
112.3; 105.4 | — |
Summary
The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith & Nephew BCS TKA and compared these kinematics data to those of normal knees.
Eligibility Criteria
Inclusion Criteria
- Must have must either a Smith & Nephew Journey II PCR or BCR TKA
- Must be at least three months post-operative
- Must have a Knee Society score of >90 with no ligamentous laxity or pain
- Weigh 250 pounds or less
- Should have good-to-excellent post-operative flexion
- Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend
- Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
- Must have body mass index (BMI) of less than 38
- Must be between 40-85 years of age
- Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to participate in the study
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
- Subjects without the required types of knee implants
- Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
- Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
Data sourced from ClinicalTrials.gov (NCT03088748). 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.