No registrations found.
ID
Source
Brief title
Health condition
Arthroplasy, Knee, RSA
Sponsors and support
Intervention
Outcome measures
Primary outcome
Migration of the implant using Rontgen Stereophotogrammetric Analysis (RSA).
Secondary outcome
1. Knee disability and Osteoarthrities Outcome Scale (KOOS);
2. Visual Analogue Scale (VAS) for Pain;
3. Short Form (SF) 36;
4. Kujala score.
Background summary
Rationale:
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.
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.
Study population:
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for Total Knee Arthroplasty.
Intervention:
Patient in all groups receive an ACS knee arthroplasty, the difference between the groups is the type of fixation of the implant.
Main study parameters/endpoints:
The mains study parameter is the migration of the implants measured with RSA.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
Study objective
1. The cemented component tibia performs better than the uncemented tibia component;
2. The uncemented femoral component performs better than the cemented femoral component;
3. The migration of the uncemented femoral component is not altered by cementing of the tibial component.
Therefore hypothesizing that for the ACS hybrid fixation is the optimal solution.
Study design
Baseline, direct postoperative, 3 months, 6 months, 1 year, 2 years, 5 years, 10 years.
Intervention
Placement of a cemented, uncemented or Hybrid ACS® knee arthroplasty.
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Inclusion criteria
1. Patients with disabling osteoarthritis and/or destruction of the knee joint scheduled for knee arthoplasy;
2. Patients in the age between 21-80 years;
3. Patients with a BMI<35;
4. Patients in stable health, suitable for surgery, and able to participate in the follow-up program;
5. Patients who signed Written Informed Consent.
Exclusion criteria
1. Patients with revision of uni or Total Condylar knee exchange;
2. Patients who are skeletal immature;
3. Patients with Charcot Joints;
4. Patients who have had a patellectomy;
5. Patients who are unable or unwilling to cooperate in follow¬-up program;
6. Patients who have a live expectancy less than 5 years;
7. Patients who are mentally or cognitively disturbed.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3730 |
| NTR-old | NTR3893 |
| CCMO | NL42872.048.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON47751 |