|- candidate number||23480|
|- NTR Number||NTR5524|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-dec-2015|
|- Secondary IDs||610 NL54336.048.15|
|- Public Title||Functional Outcome of Vanguard XP vs CR: a single centre RCT using three dimensional fluoroscopic analysis|
|- Scientific Title||Functional Outcome of Vanguard XP vs CR: a single centre RCT using three dimensional fluoroscopic analysis|
|- hypothesis||By retaining both cruciate ligaments with a bicruciate retaining total knee prosthesis will result in better post-operative knee kinematics and functionality.|
|- Healt Condition(s) or Problem(s) studied||Total knee arthroplasty, Anterior cruciate ligament|
|- Inclusion criteria||• Patient with non-inflammatory knee osteoarthritis, which is confirmed by radiology. |
• Osteoarthritis is unilateral or bilateral with the contralateral knee functioning properly, not operated on in the last 6 months and not planned for TKA in the coming 2 years.
• Patient is set to receive a primary cemented total knee arthroplasty.
• Age between 40 and 75 years, inclusive, on the day of the operation.
• Patient plans to be available for follow-up until two years post-operative.
• Patient is in stable health (ASA-score ≤ 3) and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
• Patient has a correctable or <10° rigid (non-correctable) varus or valgus deformity of the knee.
• Participants must be able to give informed consent.
|- Exclusion criteria||• Patient has a BMI > 35.|
• Patient's expected physical activity after surgery is 2 or less on the UCLA Activity Scale.
• Patient has had previous hip replacement surgery in the last 6 months, or is planned to have a hip replacement in the next 6-12 months (because of the effect on function).
• Patient has had major, non-arthroscopic surgery to the study knee, including HTO.
• Patient has an active, local infection or systemic infection
• Prior high-energy trauma to the affected knee or prior history of anterior and/or posterior cruciate ligament rupture.
• Suspicion of anterior and/or posterior cruciate ligament rupture at clinical examination.
• Documented osteoporosis with patient in active medical treatment.
• Patient has physical, emotional or neurological conditions that would compromise compliance with post-operative rehabilitation and follow-up.
• Bone quality compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis
• Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function
• Patient has knee flexion < 90 degrees
• Patient has fixed flexion deformity >10 degrees (passive extension lag)
• Patient has > 30 degrees extension deficit (active restraint to extension)
• Patient does not have a proper functioning patella tendon on the affected side; measured as inability of active extension of the knee
• Patient has quadriceps weakness on the affected side; score on MRC scale < 4 measured by research nurse
• Patient has rheumatoid arthritis, any auto-immune disorder, immunosuppressive disorder or a terminal illness.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||12-okt-2015|
|- planned closingdate||31-dec-2018|
|- Target number of participants||40|
|- Interventions||Participants will be randomly assigned to receive either the cruciate retaining or bicruciate retaining TKA both of which are commercially available and have a CE mark (Vanguard System, Biomet, Inc., USA). |
|- Primary outcome||To quantify the kinematics during functional tests the posterior femoral rollback (i.e. translation) in mm from 30° flexion to 0° extension during the step-up test will be measured. The endpoint of this parameter is set at one year post-operative.|
|- Secondary outcome||• The kinematics during functional tests are also quantified by measuring the total anterior femoral rollback in mm from 0° extension to 90° flexion during the lunge test.|
• 3D migration (i.e. translation and rotation) in mm of the tibial and femoral component of the implant referenced to the bone.
• Lateral femoral lift-off in mm at 90° knee flexion during lunge test.
• AP laxity of the knee in 20° and 90°, in mm from anterior to posterior using a rolimeter
• Functional power output of the leg using the Leg extension power rig.
• Patient and Clinician Reported Outcome Measures (PROMS and CROMS)
|- Timepoints||The patients included in the study will be seen at several moments: pre-operative, operation/direct post-operative, and 3 months, 6 months, 1 year and 2 years post-operative.|
|- Trial web site||n/a|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.R. Benard|
|- CONTACT for SCIENTIFIC QUERIES|| M.R. Benard|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||11-dec-2015 - 15-jan-2016|