|- candidate number||14493|
|- NTR Number||NTR3893|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2013|
|- Secondary IDs||NL42872.048.12 METC Slotervaarthospital|
|- Public Title||The role of Cementing on component fixation in Total Knee Arthroplasty using ACS®.|
|- Scientific Title||The role of Cementing on component fixation in Total Knee Arthroplasty using ACS®. |
|- ACRONYM||LOCKER TRIAL|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Arthroplasty , Knee|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-mrt-2013|
|- planned closingdate|
|- Target number of participants||105|
|- Interventions||Placement of a cemented, uncemented or Hybrid ACS® knee arthroplasty.|
|- 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.
|- Timepoints||Baseline, direct postoperative, 3 months, 6 months, 1 year, 2 years, 5 years, 10 years.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. D. Haverkamp|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D. Haverkamp|
|- Sponsor/Initiator ||Slotervaart Hospital|
(Source(s) of Monetary or Material Support)
|- Brief 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.
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.
Patient blinded, randomized controlled trial using Rontgen Stereophotogrammetric analysis.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for Total Knee Arthroplasty.
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.
|- Main changes (audit trail)|
|- RECORD||12-mrt-2013 - 20-mrt-2013|