|- candidate number||15498|
|- NTR Number||NTR4194|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2013|
|- Secondary IDs||MTC:12T92 ABR NL38336.096.12|
|- Public Title||Comparing preoperatively planned alignment with postoperatively achieved alignment
|- Scientific Title||Shapematching study of Unicompartmental knee arthroplasty
|- ACRONYM||UKA, CT controlled, Partial knee arthroplasty|
|- hypothesis||Shape matching: Signature™ will result in no significant difference between the alignment of the prosthesis as calculated by software and the actual alignment in vivo after knee surgery.
Shape matching: Signature™ will result in limited percentages of outliers of the limb and of the individual prothesis compoments.
|- Healt Condition(s) or Problem(s) studied||Knee, Prothesis, Computed tomography, MRI|
|- Inclusion criteria||-Patients scheduled to undergo primary UKA replacement with any of the following indications|
- Painful and disabled knee joint resulting from osteoarthritis of the medial knee compartment.
- High need to obtain pain relief and improve function
-Above 18 years old (full skeletal maturity).
-Body-mass-index (BMI) <35
-Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
-Consent form read, understood and signed by patient.
|- Exclusion criteria||-Patients with osteoarthritis of more than only the medial knee compartment|
-Active infection in knee
-Distant foci of infections which may spread to the implant site
-Failure of previous joint replacement
-Previous major knee surgery, except for arthroscopic meniscectomy.
-Metal near knee joint (MRI-scan not possible)
-Not able or willing to undergo MRI-scan and CT-scan
-Extension deficit of more than 15 degrees
-Flexion less than 110 degrees.
-Non-correctable varus axis
-Cruciate ligament insufficiency
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2013|
|- planned closingdate||31-mrt-2014|
|- Target number of participants||26|
|- Interventions|| patient specific femoral and tibial positioning guides are developed from MRI. The guides are made of polyamide and are disposable. The system fits the femoral and tibial components independently, is used with the Oxford Knee System
|- Primary outcome||To compare the preoperatively planned, computer-based Signature™ alignment plan with the actual achieved alignment in the frontal, coronal and sagittal plane in vivo postoperatively of both the femur and tibia components of the partial knee arthroplasty. |
|- Secondary outcome||Verify the fit, form and practical use of the Signature™ alignment guides.
Shape-matching: To determine the occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. Outliers are defined as deviations > 3 degrees from preoperative planning.|
Shape-matching:To determine the occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Outliers are defined as deviations > 3 degrees from preoperative planning.
Shape-matching: Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert.
Shape matching: To compare the pre operatively planned alignment of the prosthesis as determined by software and based on the MRI-scan with the actual postoperative alignment of the prosthesis placed with Signature™ in the frontal, transverse and sagittal plane (accurateness of the guides).
|- Timepoints||Pre operative, 6 weeks, 3 months, 1 year post operative|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.G.M. Schotanus|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator ||Orbis Medisch Centrum, Orthopedic Department|
(Source(s) of Monetary or Material Support)
|Orbis Medisch Centrum|
|- Brief summary||Aligning a unicompartmental knee arthroplasty (UKA) is technically demanding and associated with a significant learning curve. Recently, a new alignment method was introduced for aligning the prosthesis. This technique uses patient-specific guides to align the prosthesis.
Guides are created from a Magnetic Resonance Imaging scan (MRI). Using software (Materialise, Leuven, Belgium), the MRI scan will be segmented and assembled into a 3-Dimensional model. An alignment guide will be created for both the femur and the tibia.
With this technique it is possible to plan the position and size of the prosthesis accurately prior to surgery. During surgery, the guides serve as aligning guides for prosthesis placement.|
|- Main changes (audit trail)|
|- RECORD||4-okt-2013 - 17-okt-2013|