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Functional Outcome of Vanguard XP vs CR: a single centre RCT using three dimensional fluoroscopic analysis


- candidate number23480
- NTR NumberNTR5524
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2015
- Secondary IDs610 NL54336.048.15
- Public TitleFunctional Outcome of Vanguard XP vs CR: a single centre RCT using three dimensional fluoroscopic analysis
- Scientific TitleFunctional Outcome of Vanguard XP vs CR: a single centre RCT using three dimensional fluoroscopic analysis
- ACRONYMFOX
- hypothesisBy 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) studiedTotal 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-okt-2015
- planned closingdate31-dec-2018
- Target number of participants40
- InterventionsParticipants 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 outcomeTo 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)
- TimepointsThe 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 siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.R. Benard
- CONTACT for SCIENTIFIC QUERIES M.R. Benard
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Biomet
- Publicationsn/a
- Brief summary
- Main changes (audit trail)
- RECORD11-dec-2015 - 15-jan-2016


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