The current proposal aims to investigate the patellar tracking in patients receiving Journey II BCS total knee arthroplasty before and one year after surgery, positioned with the CORI instrumentation. The hypothesis is that less change in patella…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in patellar tracking between pre-operative and one year
post-operative measured with 4D CT imaging.
Secondary outcome
Implant positioning:
By using the CORI, we will collect implant position, perioperative ligament
laxities, alignment and tibiofemoral kinematics
PROMs:
FJS, KOOS and Kujala knee score
Background summary
Pain at the anterior side of the knee after total knee arthroplasty is still a
common phenomenon with an incidence reported to be as high as 49% [1]. The
aetiology is poorly understood and several mechanisms have been postulated.
Several studies showed an internal rotation of the femoral component to be
associated with AKP [2-4]. Classically, the optimal femoral component alignment
is thought to be perpendicular to the mechanical axis in the coronal view and
in approximately 3° external rotation relative to the posterior condylar line
(in absence of significant condylar deficiencies) or in line with the femoral
transepicondylar axis. This allows both for a balanced flexion gap and
favorable patellar tracking [3,4]. Even with the ideal position of the femoral
component, biomechanical studies show that the normal patella tracking is not
fully restored [8,9]. Furthermore, the optimal femoral component position is
driven by a balanced flexion gap and therefore heavily depending on the
alignment method. In classical mechanical alignment, the natural oblique
jointline is cut to perpendicular to the mechanical axis, this leads to
necessary external rotation of the femoral component to obtain a balanced
flexion gap. While mechanical alignment is still the golden standard in the
coronal plane, the concept of constitutional alignment is rapidly being
accepted as the way forward. There are many techniques to regain constitutional
alignment. One technique often used with good results is the restricted
kinematic alignment technique [10]. With this technique the natural oblique
jointline is recreated, resulting in internal rotation of the femoral component
relative to the transepicondylar axis to obtain a balanced flexion gap. With
this technique good clinical results are obtained and no increase in anterior
knee pain is seen [11]. Moreover, biomechanical studies even suggest superior
patellar kinematics in kinematically in comparison to mechanically aligned knee
prosthesis [12]. This is likely the result of more natural tibiofemoral
kinematics and a reduction of distal lateral femoral overstuffing, leading to
less stresses in the lateral retinaculum. Anterior knee pain can occur from a
variety of sources. A large number of free nerve endings and fibres exist,
particularly in the quadriceps muscles, retinacula, patellar tendon and
synovium. Anterior knee pain can result from any one of these sources, and
clinicians typically have difficulty identifying the exact source. Previous
studies showed that the state of the cartilage is not the only consideration.
S.F. Dye [13] asked a colleague to perform knee arthroscopy on him using local
anesthetic. His findings were instructive: he did not feel any pain in the PFJ,
whereas the capsule and prepatellar fat pad were exceptionally painful.
Therefore, it is most likely that retinacular stresses are the main reason for
anterior knee pain. Next to the influence of alignment on retinacular stresses,
as described above, overstuffing of the patellofemoral joint and instability
also lead to higher retinacular stresses and are shown to lead to anterior knee
pain [5,6,7]. These mechanisms are all related to surgical technique and
implant positioning. There are also mechanisms related to prosthesis design,
like the sagittal curve, trochlear depth and trochlea shape.
New implant designs like the Journey II prothesis are designed to replicate
optimal geometry and optimal tibiofemoral and patellofemoral kinematics. By
replicating natural rollback, cruciate stability and the oblique jointline, the
tibiofemoral kinematics of the Journey II resemble very closely the natural
knee. Moreover, the Journey II knee has an anterior dwell point and 3° varus
jointline which has been designed to restore the natural patellar tendon angle
and improve patella tracking. Therefore, the Journey II BCS seems the optimal
implant to reduce anterior knee pain. However, large registry studies show that
a higher revision rate is seen when no patellar button is used in case of the
Journey II BCS. The use of a patellar button is still under debate, but using
an onlay patella button has clear influence on the patella tracking. Therefore,
there might be a relation between the use of an onlay patella button and the
retinacular balance and thus clinical results.
With current surgical instrumentation the positioning of the prosthesis based
on the kinematics of the natural knee is challenging, and a small error can
completely counteract the normal motion defined by the implant design/geometry.
Therefore, comparative studies are only leading to new evidence when the
surgical technique is including objective and accurate tools, like the CORI
robotic platform. With the CORI, component positioning can be set based on
constitutional alignment and ligament functioning. Furthermore, the
patellofemoral compartment can be taken into account during the surgery to
enable optimal geometry replication of the trochlea in the sagittal plane. This
enables the surgeon to position the components accurately within the envelop of
motion of a specific joint.
A considerable number of cadaver studies and computer experiments have shown
that slight alterations of the shape and position/rotation of the femoral
component in TKA result in significant changes in patellar tracking and
patellar contact forces [14,15,16]. While all of these studies thoroughly
investigate the patellar tracking patterns and patella position, the
correlation between changes in pre- and postoperative patella tracking and
clinical results remain unknown. Since changes in retinacular stresses are very
likely the most important source of anterior knee pain, comparison between pre-
and postoperative tracking are mandatory to relate to clinical results.
With new emerging imaging techniques we are able to investigate in vivo patella
tracking. One of these promising techniques is the 4D CT imaging. Within the
Radboudumc we are the first in the world to use this technique actively in
patellofemoral instability patient evaluation. In the past half year we
optimized this technique with the use of the geometry files of the Journey II
BCS and cadaver experiments to use this technique on total knee arthroplasty
patients. This technique is proven to be accurate within 1 mm and 1° and
therefore useful to investigate the patellofemoral compartment.
References:
1. Popovic N and Lemaire R. Anterior knee pain with a posterior-stabilized
mobile bearing knee prosthesis: the effect of femoral component design. J
Arthroplasty 2003;18(4):396-400.
2. Barrack RL, Schrader T, Bertot AJ, Wolfe MW and Myers L. Component rotation
and anterior knee pain after total knee arthroplasty. Clin Orthop Relat Res
2001;392:46-55.
3. Berger RA, Crossett LS, Jacobs JJ and Rubash HE. Malrotation causing
patellofemoral complications after total knee arthroplasty. Clin Orthop Relat
Res 1998;356:144-53.
4. Akagi M, Matsusue Y, Mata T, Asada Y, Horiguchi M, Lida H et al. Effect of
rotational alignment on patellar tracking in total knee arthroplasty. Clin
Orthop Relat Res 1999;366:155-63.
5. Kelly MA. Patellofemoral complications following total knee arthroplasty.
Instr Course Lect 2001;50:403-7.
6. Pierson JL, Ritter MA, Keating EM, Faris PM, Meding JB, Berend ME et al. The
effect of stuffing the patellofemoral compartment on the outcome of total knee
arthroplasty. J Bone Joint Surg Am 2007;89(10):2195-203.
7. Petersen W, Rembitzki IV, Bruggemann GP, Ellermann A, Best R, Koppenburg AG
et al. Anterior knee pain after total knee arthroplasty: a narrative review.
Int Orthop 2014 Feb;38(2):319-28.
8. Barink M, Meijerink H, Verdonschot N, van Kampen A and de Waal Malefijt M.
Asymmetrical total knee arthroplasty does not improve patella tracking: a study
without patella resurfacing. Knee Surg Sports Traumatol Arthrosc
2007;15(2):184- 91.
9. Ostermeier S, Buhrmester
Study objective
The current proposal aims to investigate the patellar tracking in patients
receiving Journey II BCS total knee arthroplasty before and one year after
surgery, positioned with the CORI instrumentation. The hypothesis is that less
change in patella tracking before and after surgery will lead to less anterior
knee pain complaints. Patella tracking is investigated using 4D CT imaging.
Study design
Randomized controlled trial with two arms. Randomization for the use of an
onlay patella button or not with the Journey II prosthesis.
Intervention
Group 1 will receive a total knee replacement surgery without the placement of
a patella component.
Group 2 will receive a total knee replacement surgery with the placement of a
patella component.
Study burden and risks
The CT scans add to the level of radiation experienced by a person. For this
study this level is set at an intermediate risk. No additional risks are
associated with this study as all materials used are CE-marked and used within
intended use.
Potential burden for the patient is predominantly time and additional radiation
exposure.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
• Non-inflammatory knee osteoarthritis, which is confirmed by radiology.
• Osteoarthritis is unilateral or bilateral with the contralateral knee
functioning properly, not operated on in the last 6 months.
• Set to receive a primary cemented total knee arthroplasty.
• Aged between 50 and 80 years, inclusive, on the day of the operation.
• In stable health (ASA-score <= 3) and is free of or treated for cardiac,
pulmonary, haematological, or other conditions that would pose excessive
operative risk.
• Patient has a correctable or <10° rigid (non-correctable) varus deformity of
the knee.
• Participants must be able to give informed consent.
• Patient plans to be available for follow-up until two years post-operative.
• Ability to walk for 2 minutes without walking aid
Exclusion criteria
• Valgus deformity
• BMI > 35.
• Previous hip /knee/ankle replacement surgery in the last 12 months, or is
planned to have a hip replacement in the next 6-12 months.
• Patient has had major, non-arthroscopic surgery to the study knee, including
HTO.
• Patient has an active, local infection or systemic infection
• Incomplete or insufficient tissue surrounding the knee.
• Severe damage to the medial or collateral knee ligaments and popliteal tendon
• Documented osteoporosis with patient in active medical treatment.
• Patient has physical, emotional or neurological conditions that impacts gait
or balance, or would compromise compliance with post-operative rehabilitation
and follow-up.
• Bone quality compromised by disease or infection which cannot provide
adequate support and/or fixation to the prosthesis
• Knee flexion < 90 degrees
• > 30 degrees extension deficit (active restraint to extension)
• Patient does not have a proper functioning patella tendon on the affected
side; measured as inability of active extension of the knee
• Patient has active rheumatoid arthritis, any auto-immune disorder,
immunosuppressive disorder or a terminal illness.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77819.091.21 |
| Other | voorheen: NL9733. Gezien het NTR niet meer beschikbaar is zal dit onderzoek ook worden geregistreerd in ClinicalTrials.gov |