The goal of this study is to compare the initial and long term clinical results and survival of the uncemented and cemented Oxford knee prosthesis.- Does the fixation method affect the knee pain?- Are the radiological criteria for success used for…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiological evaluation, function radiology and survival
Secondary outcome
Pain and function
Background summary
The unicompartmental knee prosthesis is a proven treatment for patients with
medial gonartrosis. Knee prosthesis are traditionally fixed with bone cement.
However cementing takes 10-20 minutes additional operation time, waste cement
can be left in the joint space and bone cement can in time become brittle.
Therefore uncemented fixation methods have been develop which might improve
the long term survival.
Study objective
The goal of this study is to compare the initial and long term clinical results
and survival of the uncemented and cemented Oxford knee prosthesis.
- Does the fixation method affect the knee pain?
- Are the radiological criteria for success used for the cemented Oxford
prosthesis also true for uncemented fixation.
- Are the middle and long term clinical results of the uncemented Oxford at
least as good as for the cemented Oxford?
- Does the uncemented fixation improves the long term survival?
Study design
Prospective randomized multi center study
Intervention
Placement of an Oxford hemi knee prosthesis, for the study group the uncemented
version and for the control group the cemented version.
Study burden and risks
All patients have the standard risk for an unicompartmental knee prosthesis.
The clinical results if the uncemented Oxford knee are unknown, however they
are expected to be equal to the cemented Oxford. The uncemented Oxford is
expected to give a better recovery and longer survival, however they might give
early loosening because of insufficient early fixation. The patient will obtain
the traditional rehabilitation protocol, during the standard outpatient visits
additional questionnaires concerning function and pain will be taken.
Toermalijnring 600
3301 DB Dordrecht
Nederland
Toermalijnring 600
3301 DB Dordrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Gonartrosis of the knee isolated to anteromedial side
- Both cruciate ligaments must be intact.
-
Exclusion criteria
- Infection
- no informed consent
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 | NL21641.096.08 |