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Clinical and radiological evaluation of Signature™ Unicompartmental knee arthroplasty A Prospective, Multi-centre, Randomized, Double blind study Orbis Medisch Centrum, Sittard, the Netherlands.


- candidate number15769
- NTR NumberNTR4278
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2013
- Secondary IDsIRB: 12T92 
- Public TitleClinical and radiological evaluation of Signature™ Unicompartmental knee arthroplasty A Prospective, Multi-centre, Randomized, Double blind study Orbis Medisch Centrum, Sittard, the Netherlands.
- Scientific TitleClinical evaluation of the Signature™ UKA
- ACRONYMUKA, PKA, Microplasty, Signature, Patient Specific
- hypothesisThe aims of this study are: to investigate whether the new device is at least as effective and safe in clinical outcome as the widely used current method; to investigate whether a larger percentage of prosthesis is placed correctly (within guidelines of 3 degrees varus and 3 degrees valgus)
- Healt Condition(s) or Problem(s) studiedRandomized controlled trial, Patient specific, Signature, Alignment, Uni Knee arthroplasty
- 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
-Ablility and willingness to follow nstructions, including control of weight and iactivity 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
-General infection
-Distant foci of infections which may spread to the implant site
-Failure of previous joint replacement
-Pregnancy
-Previous major knee surgery, except for arthroscopic meniscectomy. -Metal near knee joint (MRI-scan not possible)
-Not able or willing to undergo MRI-scan
-Reumatoid arthritis
-Extension deficit of more than 15 degrees
-Flexion less than 110 degrees
-Non-correctable varus axis
-Cruciate ligament insufficiency
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate31-jan-2024
- Target number of participants120
- InterventionsSignature™ for UKA utilizes patient specific femoral and tibial positioning guides, developed from MRI. The guides are made of polyamide and are disposable. The Signature™ system, which fits the femoral and tibial components independently, is used with the Oxford Knee System.
- Primary outcomePrimary outcome is relief of pain and restoration of function, measured by the Oxford knee score (OKS), at 1 year post-operative. Furthermore, this questionnaire will be completed in all post-operative visits.

In order to measure positioning of the prosthesis long-leg, weight-bearing, standing anteroposterior and screened antero-posterior and lateral radiographs will be made at 6 weeks post-operative. The baseline mechanical axis will be measured as the angel between a line connecting the center of the femoral head with the center of the knee and the line connecting the center of the knee with the center of the ankle. Measurements will be performed by an orthopaedic resident.
- Secondary outcomeRelief of pain, restoration of function and patient satisfaction as determined by answers to patient outcomes questionnaires: American Knee Society Score, WOMAC, Oxford Knee-12, VAS and EQ-5D.
•American Knee Society Score, WOMAC and Oxford Knee-12, VAS, EQ-5D at pre operative, 3 months, 1 year, 2 years, 5 and10 years postoperative. KSS and VAS will be obtained by a physician assistant or nurs practioner who was not present when operation was being performed and is therefore blinded concerning the type of prosthesis that is being placed. WOMAC, Oxford Knee-12 and EQ-5D will be completed by the patients.

Operation time
Time will be recorded from the moment of incision until bandage is being placed. In order to also measure the possible gain in time for the operative procedure as a whole, time will be recorded from the moment personnel starts to install materials on sterile fields until bandage is being placed. Recorded times will be registered by the knee surgeon on the standard operative record for each patient individually and in the study database for all patients participating in the trial.

Length of hospital stay (in days) will be registered for both groups.

Adverse events/complications Complication registration will be done throughout the entire study period on a digital complication registration form
•Infection
Infection lab values (ESR, CRP, leukocytes) will be measured on day 3 post-operative to screen for the presence of infection. When infection is indeed present, this will be noted on the complication registry form and appropriate action will be taken. Distinction will be made clinically between superficial infections and deep infections.
•Trombo-embolic complications
Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism. When clinical signs are present, diagnostic tools will be used to analyse if DVT or PE are indeed present. If DVT or PE are indeed present, this will be noted on the complication registration form and appropriate action will be taken.

•Wound problems
Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting longer than 5 days after surgery.
•Loosening
Clinical signs of loosening of tibial or femoral components of the prosthesis with confirmation of loosening on radiographs.

Needed change of plans
When change of the size of the prosthesis is needed to obtain appropriate placement, this will be recorded. This means that the prosthesis, or at least part of the prosthesis (tibial, femoral component or insert), delivered by Biomet together with the guides will not be used and will be sent back to Biomet.
When, for whatever reason, conversion of the Signature procedure to conventional procedure is needed, this will be recorded, together with the reason for conversion. Moreover, the fit of the guides will be assessed during operation. If suboptimal fit would occur, this will be registered.

Survivorship at 10 years post-operative A prosthesis will be considered as ‘survivor’ in the absence of revisions/removal due to pain and/or loosening and in the absence of radiological signs of loosening (that can be observed on the above mentioned long-leg, weight-bearing, standing anteroposterior and lateral radiographs if
- TimepointsPre operative, 6WK, 3M, 1Y, 2Y, 5 + 10Y
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum, Orthopedic Department
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum, Department of Orthopedic Surgery
- PublicationsN/A
- Brief summaryAligning 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. First, this technique is expected to result in a greater percentage of prosthesis placed correctly (within guidelines of 3 degrees varus and 3 degrees valgus) as with conventional guiding because computer software is used to determine the correct position of the prosthesis. Secondly, this method for alignment of the knee is expected to result in shorter surgical operation time because it is less invasive and less surgical instruments are needed. The potential risk of deep infection is therefore reduced with this technique. No difference is expected in clinical results between this new technique and the conventional alignment method. The aims of this study are: to investigate whether the new device is at least as effective and safe in clinical outcome as the widely used current method; to investigate whether a larger percentage of prosthesis is placed correctly (within guidelines of 3 degrees varus and 3 degrees valgus)
- Main changes (audit trail)
- RECORD26-nov-2013 - 18-dec-2013


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