This new developed knee prosthesis will be compared to the standard scorpio PS knee prosthesis. In this comparison it will be examined ifthe changes in design really do improve function and deminish pain. Allso patella tracking and patella tilting…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As primary study parameter the maximal flexion will be compared between the two
prostheses.
Secondary outcome
As secondary study parameters the complications will be registered and a
comparison will be done of the chair raise and stair climb test
with the corresponding pain score, and the operation time
Background summary
Knee prostheses consist of several different kinds of design developed to
optimize a certain part of the function of the knee. standard knee
prosthesis consists of a femoral component a tibial component and an insert in
between these two to make movement as smooth as
possible.
Dependent on the design of the several parts of a prosthesis the main aim can
be optimising total flexion, better possibility to kneel, or
numerous other specific functions.
The NRG knee prosthesis as a specific design developed to optimize maximum
flexion en decrease post-operative anterior knee pain
Study objective
This new developed knee prosthesis will be compared to the standard scorpio PS
knee prosthesis. In this comparison it will be examined if
the changes in design really do improve function and deminish pain. Allso
patella tracking and patella tilting will be copared.
Study design
It is a prospective single center single blind randomized clinical trial. After
pre-operative screening and X-rays 88 patients of the AZM will
have a normal total knee replacement operation. 44 patients will get the
scorpio NRG knee prosthesis and 44 patients will get the Scorpio
PS knee prosthesis. Post-operatively the patients will have a check up at 6
wkeeks 3 months 6 months 1 year 2 years and 5 years. At these
check ups a knee society score, a chair raise and stair climb test will be
done, complications will be registered, a womac patient self
evaluation will be done and X-rays will be taken.
Intervention
All patients will have a total knee replacement operation during which the
study knee or the control knee prosthesis will be implanted
Study burden and risks
The risks for the patients are the standard risks of a total knee replacement
surgery. A surgery which the patient also will have if he/she
does not participate in the study.
At each visit two extra X-rays will be taken of which the radiation exposure
will be largely beneath the allowed exposure.
koeweistraat 8
4181 CD Waardenburg
NL
koeweistraat 8
4181 CD Waardenburg
NL
Listed location countries
Age
Inclusion criteria
age between 18 and 80 years
male and non-pregnant female
patients requiring a primary TKA
Exclusion criteria
patients with BMI higher than 35
patients with active infection
patients with malignancy
patients requiring revision surgery of a previous implanted total knee system
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 | NL31488.068.10 |