The main objective is measuring the difference in initial migration with means of Rontgen Stereophotogrammetric analysis (RSA) of the different types of fixation. The secondary objective is comparing the QoL and long term survival between groups.…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mains study parameter is the migration of the implants measured with RSA.
Secondary outcome
The Secondary outcome is the Quality of Life differences and the long term (10
year) follow up regarding revision rates.
Background summary
For many designs of Knee arthroplasty it remains unsure whether cemented or
uncemented fixation of the components has the best long term survival. Many
authors even claim that hybrid fixation (uncemented femur and cemented tibia)
is the optimal solution.
Study objective
The main objective is measuring the difference in initial migration with means
of Rontgen Stereophotogrammetric analysis (RSA) of the different types of
fixation. The secondary objective is comparing the QoL and long term survival
between groups. The hypothesis is that a cemented tibial plateau and an
uncemented femoral component has the least migration.
Study design
Patient blinded, randomized controlled trial using Rontgen
Stereophotogrammetric analysis.
Intervention
Patients in all groups receive an ACS knee arthroplasty, the difference between
the groups is the type of fixation of the implant.
Study burden and risks
All patient will be seen at regular follow up intervals identical to the normal
knee arthroplasty protocol. At these visits a additional RSA X-ray will be made
and the patient will be asked to fill out a questionnaire. During the study 5
RSA X-rays per patient will be made, and during 7 follow up visits we will ask
the patient to fill in a questionnaire.
All groups consist of treatments that are regularly used, with an implant that
is available for more than 10 years and is sold worldwide over 100.000 times.
Bearing this in mind we judge the study as safe.
Laarderhoogtweg 12
Amsterdam 1101EA
NL
Laarderhoogtweg 12
Amsterdam 1101EA
NL
Listed location countries
Age
Inclusion criteria
Age 21-80
BMI<35
Symptomatic Osteoarthritis of the knee
In stable health, suitable for surgery and able to participate in follow up.
Exclusion criteria
Charcot Joint
Previous surgery (excluding arthroscopy)
Design
Recruitment
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 | NL42872.048.12 |
| OMON | NL-OMON26032 |