N/A
N=5
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System
Total Knee Arthroplasty · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02204748 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend — -4.89; -2.58 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DePuy Attune posterior stabilizing fixed bearing knee system (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend |
-4.89; -2.58 | — |
| PRIMARY Femoro-tibial Kinematics: Translation and Lift-off for Gait |
-0.8; 0.24 | — |
| PRIMARY Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down |
-1.35; -0.58 | — |
| PRIMARY Femoro-tibial Kinematics - Deep Knee Bend |
2.99; 118.2 | — |
| PRIMARY Femoro-tibial Kinematics - Gait |
1.28; 19.4 | — |
| PRIMARY Femoro-tibial Kinematics - Ramp Down |
0.97; 28.6 | — |
| SECONDARY Max Ground Reaction Force - Deep Knee Bend |
75.3 | — |
| SECONDARY Max Ground Reaction Force - Gait |
106.0 | — |
| SECONDARY Max Ground Reaction Force - Ramp Down |
97.2 | — |
Summary
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there is no hypothesis.
Eligibility Criteria
Inclusion Criteria
- At least three (3) months post-operative with no other surgical procedures conducted within the past six months
- Between 30-80 years of age
- Body weight of less than 280 lbs
- Must be between 160cm (5'3) and 193cm (6'4) tall
- Body Mass Index (BMI) >18.5 and <35
- Judged clinically successful with a Knee Society score (KSS) of greater than 80
- Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
- Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
- Will have a DePuy Attune PS TKA
- Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study
Exclusion Criteria
- Pregnant or potentially pregnant females will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT02204748). 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.