Osteoarthritis Clinical Trial
Official title:
Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per
year. Statistics indicate that for patients over 60 year old approximately one out of 20 will
require corrective reoperations within 10 years after surgery. However, for patients younger
than 60 years, approximately one out of 10 will require revision total knee arthroplasty
within 10 years of surgery. As the number of younger patients is increasing, there has been a
shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and
implant longevity being the important issues for quality of patient care. Furthermore, it has
been reported that up to 25% of patients are not satisfied with the functional results of
their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However
these are often static, because of even most advanced x-ray film exchanger limit the number
of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real
time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.
The purpose of this study is to investigate the effect of a new implant design on the
post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A
prospective randomized study will be performed on a new implant: the DePuy ATTUNETM
fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
The main goal of this study is to investigate the effect of a new implant design on the
postoperative active knee kinematics on mid-flexion instability of the joint. Data will be
collected during the surgery with a Computer Assisted Surgery system and in the post
operative follow up phase using the dynamic RSA focusing. A prospective study will be
performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS)
knee prosthesis.
Kinematic tests will be performed to analyze femoral rotation patterns and translation
patterns of the medial and femoral condyle respect to the tibial plateau during different
daily life motor tasks.
Despite reportedly good implant survival rates, not all patients are fully satisfied after
total knee arthroplasty (TKA). One of the most debated topics in TKA is the effectiveness of
the prosthesis to reproduce physiological kinematics at the replaced knee, usually expressed
in terms of patterns of joint rotation in the three anatomical planes, of the functional
axis, and of the tibio-femoral contact points on the medial and lateral condyles, that is,
femoral roll-back.
Implant design can influence final kinematic results. The mid-flexion instability may be the
cause of joint instability, paradoxical femoral rollback, surgical variation.
Recently an improved implant design of fixed bearing PS DePuy implant has been anticipated to
early users. This implant has been claimed to reduce midflexion instability and improve joint
kinematics, because of a particular multiradius shape of the condylar surface.
For intra-operative kinematic acquisition, a commercial navigation system (BLUIGS, Orthokey
Italia srl, Firenze, Italy) with a dedicated software for kinematic tests will be used.
In the present study, the investigators will use a postoperative bi-planar imaging method in
weight-bearing motor tasks with active muscle contraction , to determine the in vivo contact
areas on the tibial articulating surface of a PS TKA during flexion of the knee.
The objective of the present study is to determine the contact areas and their movement
through a 0-140° arc of motion in both the anteroposterior (AP) and ML directions. The cohort
will also be compared with data of normal knee kinematics, as reported in current literature.
At 6 months follow-up, dynamic fluoroscopy will be used to analyze implant kinematics (i.e.
stair descent, level-walking and non weight-bearing maximum knee flexion) and a simultaneous,
real-time collection of ground reaction forces with a force platform will be performed.
Clinical scores will be collected at that time and compared with all the data registered
before surgery and during the follow up routinely made at 1 and 3 months after surgery.
A specifically developed device installed at the Rizzoli Orthopaedic Institute will be used
to assess the kinematic of the knee at 9 months after surgery. This equipment is unique
worldwide: it was specifically designed, built and certified for dynamic and static RSA
evaluation of TKA. The purpose of this study is to investigate the effect of a new implant
design on the post-operative active knee kinematics, focusing on mid-flexion instability of
the joint. A prospective randomized study will be performed on a new implant: the DePuy
ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Recruiting |
NCT03167502 -
Performance in Walking in Osteoarthritis Patients
|
N/A | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |