The aim of this study is to compare the early post-operative migration as measured by Roentgen Stereophotogrammetric Analysis (RSA) of the cemented tibial component with the uncemented porous coated tibia component.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Migration parameters:
- Maximum total point migration (MTPM)
- Maximum subsidence
- Maximum lift-off
Secondary outcome
Clinical evaluation:
- IKSS (International Knee Society Score)39
- SF36 (Short Form (36) health survey)40
- KOOS (Knee injury and Osteoarthritis Outcome Score)41
- Range of motion of the knee
Background summary
The most important failure mechanism of TKA, apart from polyethylene wear, is
aseptic loosening of the implant. Failure risk is mainly determined by the
quality of fixation and mechanical characteristics of the prosthesis. In
literature, the issue whether or not to use cement in TKA is not yet resolved.
Cement is reported to cause damage, either by its toxicity or due to the heat
used for polymerisation. Finally, cement might leak and destruct the
polyethylene layer of the prosthesis. Cementless prostheses are designed to
allow osseointegration in order to provide a stronger and longer lasting
fixation and a more physiological load transfer between the bone and the
prosthesis.
Study objective
The aim of this study is to compare the early post-operative migration as
measured by Roentgen Stereophotogrammetric Analysis (RSA) of the cemented
tibial component with the uncemented porous coated tibia component.
Study design
This clinical study is a prospective randomised RSA-controlled non-inferiority
trial. 42 patients will be included in the AMC, 21 in the treatment (uncemented
tibia component) and 21 in the control (cemented tibia component) group.
Intervention
The patient will receive either the cemented tibial component (control group)
or the uncemented porous coated tibial component (intervention group)
Study burden and risks
The effective radiation dose per RSA-radiograph is 3µSv. The additional annual
radiation dose is negligible if the natural exposure of 2 mSv is considered.
The effective radiation dose of a standard knee radiograph is 0,01 mSv.
Theoretically, the use of tantalum markers is associated with a slightly
elevated risk of infection. However, in literature no mention of this elevated
risk can be found. Other potential risks are risks associated with normal total
knee replacements such as infection, migration, bone loss, pain, loosening of
components, tromboembolic complications and risks involving anaesthesia.
Meibergdreef 9
1100 DD
NL
Meibergdreef 9
1100 DD
NL
Listed location countries
Age
Inclusion criteria
•Patients diagnosed with osteoarthritis or rheumatoid arthritis of the knee requiring primary total knee arthroplasty
•Patients capable of giving Informed Consent and expressing willingness to comply with the post-operative follow-up program
•Patients having no major deformities, i.e. sagittal and coronal deformities are less than 15 degrees
Exclusion criteria
•Patients requiring revision arthroplasty
•Patients unable or unwilling to sign the Patient Informed Consent specific to this study
•Patients with osteoporosis of the tibial plateau
•Patients with functional impairment of any other lower extremity joint besides the operated knee
•Patients having a flexion contracture of 15° and more
•Patients having a varus or valgus contracture of 15° and more
•Patients having insufficient understanding of Dutch language to participate
•Patients incompetent to fill in the clinical scores
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34096.018.10 |