The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are migration of the femoral and tibial components
measured with model-based RSA software till 10 years postoperatively.
Furthermore, the stability of the markers will be determined and the
complications due to the markers and/or the marker inserter will be registered.
Secondary outcome
The secondary parameters are wear, inducible displacement, survival, clinical
outcomes and complications up to 10 years postoperatively.
Background summary
The choice whether or not to preserve the posterior cruciate ligament (PCL) in
total knee arthroplasty (TKA) is coupled to the use of a PCL-retaining (CR) or
a condylar stabilizing (CS) insert. The CS insert is anterior-lipped (AL) to
prevent anterior translation of the femur on the tibia with flexion and
compensate the function of the PCL. Currently both the CR and CS insert are
made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear
related osteolysis. However, this also might diminish the fracture toughness
and crack propagation of the insert. We expect that due to the high contact
forces on the anterior lip of the CS insert during flexion, especially in
younger and more active patients, and the lower fracture toughness of HXPLE,
the CS insert might show more migration, wear or other damage compared to the
CR insert in the long-term, which might lead to more revisions in the CS insert
compared to the CR insert.
To measure the migration and wear, during surgery tantalum markers will be
inserted in the host bone using a marker inserter. The displacement of the
prosthesis with reference to the host bone will be measured using model-based
RSA. Both the tantalum markers and the inserter are already used for study
purposes. However, the safety and usability are not registered before.
Study objective
The primary objective is to compare the migration of both the femoral and
tibial component by the use of a CS insert or CR insert both made of HXPLE
using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore,
the safety and usability of the tantalum markers and the marker inserter will
be determined. The secondary objective is to determine the influence of the
type of insert on the wear, inducible displacement, survival and clinical
outcomes.
Study design
A randomized controlled trial
Intervention
One group receives an uncemented total knee prosthesis with a CS insert, while
the other group receives an uncemented total knee prosthesis with a CR insert.
Both will be placed using the MAKO-robotic arm using a kinematic balancing
technique.
Study burden and risks
There are no additional risks expected for the CS or CR insert used in the
uncemented total knee prosthesis as compared to risks for other prostheses, as
these prostheses are used for standard care in clinical practice. Also the
MAKO-robotic arm is already used in clinical practice. Also the markers and
marker inserter are used before without any problems in comparable studies.
Patients are asked to spend time to fill in the questionnaires and to have
extra visits to the hospital consisting of an examination and radiographs, next
to the standard visits. The possible benefit from participation in this study
might be that patients have more follow up visits, which has as advantage that
possible complications might be noticed earlier compared to normal follow up.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
• Patients scheduled to undergo primary total knee replacement with the
MAKO-robotic arm, with one of the following indications:
o Painful, disabling joint disease of the knee resulting from: non-inflammatory
degenerative joint disease (including osteoarthritis, traumatic arthritis or
avascular necrosis) or rheumatoid arthritis.
o One or more compartments are involved;
o Moderate varus, valgus, or flexion deformity in which the ligamentous
structures can be returned to adequate function and stability (meaning a varus,
valgus or flexion deformity < 15 degrees);
• Age between 18 and 70 years;
• ASA score I or II;
• A good nutritional state of the patient;
• Patients with a completely intact PCL at the time of surgery;
• Patient is able to understand the study and is willing to participate and to
sign the Informed Consent;
• Patient is able to speak and write Dutch.
Exclusion criteria
• Contraindications of the manufacturer;
• Metal in the operative or non-operative leg which lead to the creation of
accuracy-reducing artefacts in the CT scan;
• Body Mass Index (BMI) of > 35 kg/m2;
• Flexion contracture of 15 degrees and more;
• Varus/valgus contracture of 15 degrees and more;
• History of total or unicompartmental reconstruction of the affected joint;
• Bilateral operation;
• A Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side
within the last year that is considered to have an unsatisfactory outcome
(Patients with contralateral and/or ipsilateral THA > 1 year ago with good
outcome can be included in the study);
• A Total Knee Arthroplasty (TKA) on contralateral side within the last 6
months that is considered to have an unsatisfactory outcome. (Patients with
contralateral TKA > 6 months ago with good outcome can be included in the
study);
• Patients who will need lower limb joint replacement for another joint within
one year.
• Active or suspected latent infection in or about the knee joint;
• Osteomyelitis;
• Sepsis;
• A systemic or metabolic disorder leading to progressive bone deterioration,
excluding rheumatoid arthritis;
• Vascular insufficiency, muscular atrophy;
• Neuromuscular or neurosensory deficiency, which would limit the ability to
assess the performance of the device;
• Female patients planning a pregnancy during the course of the study;
• The patient is immunologically suppressed or receiving steroids in excess of
normal physiological requirements.
• Patients bone stock is compromised by disease or infection which cannot
provide adequate support and/or fixation to the prosthesis;
• A knee fusion to the affected joint;
• Patient has a known or suspected sensitivity or allergy to one or more of the
implant materials;
• Insufficient bone stock to provide adequate support and/or fixation to the
prosthesis;
• Unable or unwilling to sign the Informed Consent specific to this study.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80554.058.23 |