Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04855864 |
| Other study ID # |
S64561 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 8, 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Hilde Vandenneucker |
| Phone |
+32 16 33 88 29 |
| Email |
hilde.vandenneucker[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Today, primary total knee arthroplasty (TKA) is considered to be a safe and successful
therapy for end-stage osteoarthritis of the knee. In the past decades, different total knee
prostheses have been released on the market showing minor or more important differences in
design features.
Smith and Nephew® (Memphis, Tennessee, USA) introduced a new posterior sacrificing (PS)
design in 2005, which was called Journey BCS®, a bicruciate stabilizing design throughout
knee flexion. This second generation guided motion total knee system prevents not only tibial
posterior translation, but also limits tibial anterior translations by articulation between
post and femoral box. As a consequence of the good results in the older population group, an
increasing amount of younger and more active patients receiving TKA can be observed. In
general, this age group scores remarkable lower in satisfaction. A possible explanation is
the absence of anterior cruciate ligament (ACL) in these designs, which still causes abnormal
kinematics. Therefore, in a further step, the research has been focusing on preserving both
cruciate ligaments within the same basic design as Journey BCS®, keeping the curvature and
contour of the femoral and tibial component, as well as the joint line principles.
Consequently, a bi-cruciate retaining (BCR) design was developed, preserving both the ACL and
posterior cruciate ligament (PCL) vessels.
BCR TKA of Smith & Nephew, called Journey XR®, has a clear potential to result in a better
functional outcome while avoiding the limitations and complications of previous other designs
so that previously disappointing results of the pasts are not confirmed. As a result,
patients are expected to be more capable to return to an active lifestyle with normal
kinematics and proprioception of the knee. New insights in biomechanics, kinetics and
proprioception in native knee and TKA make higher interest in BCR TKA inevitable. Yet, there
is no prospective clinical trial available that compares Journey BCS® with Journey XR® from
Smith & Nephew in regard to PROMS, functional performance including gait analysis, survival
and revision rates.
Description:
Today, primary total knee arthroplasty (TKA) is considered to be a safe and successful
therapy for end-stage osteoarthritis of the knee. In the past decades, different total knee
prostheses have been released on the market showing minor or more important differences in
design features. As such, knee prostheses can differ in the level of constraint they provide.
More specifically, for a few decades, two main designs were available for clinical use.
First, designs that only sacrifice the anterior cruciate ligament (ACL), but retain the
patient's own posterior cruciate ligament (PCL), the so-called cruciate retaining (CR)
design, and secondly, designs that sacrifice the patient's ACL and PCL, the so-called
posterior sacrificing (PS) design. The CR design has been considered historically as the
least constrained design. The containment can be adjusted by equalizing the cavity and
geometry of tibial end femoral surfaces. The PS knee design, known by the cam-post mechanism,
offers more constrain, but sacrifices both cruciate ligaments. In terms of complications and
outcome no difference can be found between PS and CR knee designs. However, the last decade,
prosthetic research focused more and more on the preservation of both PCL and ACL, in an
attempt to mimic better natural kinematic behaviour of the knee and to keep the
proprioceptive function of the ACL and PCL vessels.
Smith and Nephew® (Memphis, Tennessee, USA) introduced a new PS design in 2005, which was
called Journey BCS®, a bicruciate stabilizing design throughout knee flexion. This second
generation guided motion total knee system prevents not only tibial posterior translation,
but also limits tibial anterior translations by articulation between post and femoral box.
The main purpose of this type of TKA was to achieve a more normal and natural kinematic
behavior with more lateral posterior roll back, while keeping the medial side stable and
preserving the normal natural joint line inclination. In particular, the medial femoral
condyle is more distal than lateral condyle. There is a 3° varus joint line and the convex
lateral tibial surface in sagittal plane creates a slight posterior slope. More anterior
translation of the femur is seen with CR design during flexion allowing possibly little more
flexion in BCS design. However, although the specific design properties of this prosthesis
tended to mimic the stabilizing function of the natural cruciate ligaments much better, the
patient's ACL is still sacrificed and at least its proprioceptive function is still
completely lost. Mid-term results of Journey II BCS® are similar compared to other knee
designs. However, the younger population group seems to end up with better scores when
looking at postoperative clinical and functional results. As a consequence of the good
results in the older population group, an increasing amount of younger and more active
patients receiving TKA can be observed. Unfortunately, a significant part of these young
patients keeps complaining of residual symptoms and pain in the knee after TKA. In general,
this age group scores remarkable lower in satisfaction. A possible explanation is the absence
of ACL in these designs, which still causes abnormal kinematics. Furthermore, the loss of its
proprioceptive function might be a factor in the mentioned feeling of imperfection.
Therefore, in a further step, the research has been focusing on preserving both cruciate
ligaments within the same basic design as Journey BCS®, keeping the curvature and contour of
the femoral and tibial component, as well as the joint line principles. Consequently, a
bi-cruciate retaining (BCR) design was developed, preserving both the ACL and PCL vessels.
Patients retain better knee kinematics, stability, proprioception and consequently better
functionality and satisfaction by retaining ACL in TKA. Although the design is available on
the American market for about seven years, and since 2 years also on the European market, it
is still not widely used, even not by surgeons who are familiar with the other designs of the
same prosthetic line. One of the reasons therefore might be the published higher rates of
early revisions or poly exchange of another recent design in which both cruciate ligaments
are preserved, released on the market by another prosthetic company a few years earlier.
BCR TKA of Smith & Nephew, called Journey XR®, is designed to retain both cruciate ligaments.
Journey XR® design has a clear potential to result in a better functional outcome while
avoiding the limitations and complications of previous other designs so that previously
disappointing results of the pasts are not confirmed. As a result, patients are expected to
be more capable to return to an active lifestyle with normal kinematics and proprioception of
the knee. Journey XR® preserves specific features of Journey BCS®, such as asymmetric femoral
condyles, 3° varus joint line and low constraint concave medial and convex lateral articular
surface. In order to preserve both cruciate ligaments Journey XR® design has some
adjustments, which are mentioned here. Tibial base plate design with continuous keel and
anterior bridge, consists of high-quality forged Ti-6Al-4V which is less stiff. These tibial
component updates were implemented to reduce the risk of bone resorption from stress
shielding and to double fatigue strength compared to BCR design of another company. Fixation
of tibial Journey XR® baseplate, which is provided with an asymmetrical notch to accept ACL
footprint, is based on four-corner peg fixation with maximal bone coverage and good results
compared to known knee designs with stem fixation. Furthermore, tibial insert lock is
optimized. Previous total knee designs of Smith and Nephew® already proved very limited poly
wear when using highly cross-linked polyethylene (XLPE) in combination with OXINIUM,
according to VERILAST® technology. Approximately 4000 Journey XR® procedures have been done
globally in the last 3 years in 10 countries, among which US, Japan, South Africa and some
countries in Western EU like Belgium. Currently 21% of these cases is placed using NAVIO® or
Cori robot technology but this proportion is growing. Present literature is clear that
retention of ACL and PCL has significant higher satisfaction compared to TKA patients, as
with partial knee arthroplasty. Moreover, last update of journey XR® design of 2017 had
interesting solutions for the limitations of the mentioned previous design. Problems like
tibia poly wear, tibia insert lock and implant strength were common. New insights in
biomechanics, kinetics and proprioception in native knee and TKA make higher interest in BCR
TKA inevitable. Yet, there is no prospective clinical trial available that compares Journey
BCS® with Journey XR® and the Legion PS® design from Smith & Nephew in regard to PROMS,
functional performance including gait analysis, survival and revision rates.
