|- candidate number||13243|
|- NTR Number||NTR3585|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-aug-2012|
|- Secondary IDs||P1137 METC|
|- Public Title||Visionaire RCT.|
|- Scientific Title||Stability and Alignment of Patient Matched Instrumentation compared to conventional instrumentation in Total Knee Arthroplasty: A Randomized Controlled Trial.|
|- hypothesis||The null hypothesis is that the Visionaire Patient Matched Instrumentation and the standard instrumentation produces an equal alignment and stability one year after surgery. This hypothesis will be tested two-sided, with p<0.05.|
|- Healt Condition(s) or Problem(s) studied||Total knee arthroplasty, Total knee arthroplasty, Osteoarthritis|
|- Inclusion criteria||1. Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty;|
2. Patient is 40 to 70 years of age, inclusive;
3. Patient plans to be available for follow-up through one year postoperative;
4. Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk;
5. Patient has <10 degrees fixed (non-correctable) varus or valgus deformity;
6. Patient is of the Caucasian race.
|- Exclusion criteria||1. Patient is known to have insufficient femoral or tibial bone stock;|
2. Patient has a BMI >35;
3. Patient’s expected physical activity after surgery is 2 or less on the UCLA Activity Scale;
4. Patient has had previous hip or knee replacement surgery in the last 6 months;
5. Patient is planned to have additional hip or contralateral knee replacement in the next 6 months;
6. Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee;
7. Patient has an active, local infection or systemic infection;
8. Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up;
9. Patient has grade 3 collateral ligament insufficiency (complete tear of ligament);
10. Patient has knee flexion <90 degrees;
11. Patient has fixed flexion deformity >10;
12. Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder;
13. Patient is pregnant or plans to become pregnant during course of study;
14. Patient has a known sensitivity to materials in the device and/or cutting blocks;
15. Patient has >30 degrees extension deficit;
16. Patient has contra-indications for MRI.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-aug-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||42|
|- Interventions||The trial treatments are the Visionaire Patient Matched Instrumentation or the standard instrumentation of the Genesis II. All patients will receive associated hospital preoperative, per-operative and postoperative standard care, which is identical for both types of treatment. |
|- Primary outcome||The varus/valgus laxity in flexion and extension, and the axial alignment.|
|- Secondary outcome||The secondary study parameters are the clinical, functional and radiological outcomes 1 year postoperatively.|
|- Timepoints||Preoperative data will be collected one to six weeks preoperatively. Postoperative data will be collected at 6 weeks ± 1 week, 3 months ± 2 weeks, 1 year ± 1 month. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Janneke Schimmel|
|- CONTACT for SCIENTIFIC QUERIES|| Janneke Schimmel|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|Smith & Nephew|
|- Brief summary||Rationale: |
The Visionaire Patient Matched Instrumentation is a newly developed operative strategy consisting of patient matched disposable cutting blocks as a means of preparing the bones for the implants. The blocks are a one-time use, patient specific, disposable item. The new operative strategy is a bone-oriented approach due to the use of anatomical bone landmarks. Proper balancing of the ligaments in total knee arthroplasty, along with correct positioning appears to be important as a determinant of the clinical outcome, but also to prevent laxity. Therefore, we would like to investigate to what extent this newly developed type of instrumentation results in a stable and a properly aligned knee. If this new type of instrumentation works well, then the stability and alignment of the knee will be similar or even better than the, commonly accepted, conventional instrumentation. In addition, it could be expected that the clinical, functional and radiological outcomes would be better than with the conventional instrumentation.
The primary objective of the study is to investigate whether the Genesis II prosthesis (posterior stabilized, PS) implanted with the Visionaire Patient Matched Instrumentation reproduces similar or even better (smaller standard deviation) stability and alignment than the Genesis II prosthesis implanted with the conventional instrumentation, one year after surgery.
The secondary objective of this study is to assess the clinical, functional and radiological performance/effectiveness at short-term follow-up.
The study is designed as a single-centre prospective randomized controlled trial.
Patients presenting with non-inflammatory osteoarthritis requiring unilateral total knee replacement, and 40-70 years of age.
Intervention: One group will receive the Genesis II implanted with the Visionaire Patient Matched Instrumentation and the other group with the conventional instrumentation.
Main study parameters/endpoints:
The varus/valgus laxity in flexion and extension, and the axial alignment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients participating in this study will not being barred by any additional risk other than the regular risks for a surgery of a primary knee prosthesis type Genesis II. The patients will visit the clinic at regular follow-up moments. These visits take a bit more time than regularly because at these moments the patient visits also the research nurse for data collection. The questionnaires and physical examinations of the knee do not bring any extra burden. The additional radiographic assessments increase the total amount of radiation. However, the total amount of radiation falls within the limits of the ICRP (International Commission of Radiological Protection).
|- Main changes (audit trail)|
|- RECORD||17-aug-2012 - 25-sep-2012|