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Radiological evaluation of CT vs MRI based Signature™ for total knee arthroplasty A Prospective, Randomized Study


- candidate number19289
- NTR NumberNTR4734
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2014
- Secondary IDs13T174 
- Public TitleRadiological evaluation of CT vs MRI based Signature™ for total knee arthroplasty A Prospective, Randomized Study
- Scientific TitleCT vs MRI based Signature™ for TKA
- ACRONYMCT, MRI, Patient Specific, TKA
- hypothesis• CT based Signature™ will result in a comparable percentage of prosthesis that is placed correctly (within guidelines of 3 degrees varus and 3 degrees valgus).
• CT-based Signature™ will result in a comparable alignment of the prosthesis as calculated by software and the actual alignment in vivo after knee surgery.
• CT-based Signature™ will result in comparable changes of plans.
• CT-based Signature™ will result in result in comparable percentages of outliers of the limb and of the individual prosthesis components.
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Computed tomography, MRI, Osteoarthritis
- Inclusion criteria- Patients scheduled to undergo primary TKA replacement with any of the following indications
• Painful and disabled knee joint resulting from osteoarthritis.
• High need to obtain pain relief and improve function,
- 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- 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 or CT-scan
- Rheumatoid arthritis
- Non-correctable varus axis
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-jan-2015
- Target number of participants140
- InterventionsTKA aligned either with the CT based Signature™ or the MRI based Signature™ alignment guide.
- Primary outcome• Outliers in alignment of the femoral and tibial prosthesis in the frontal plane, measured on radiographs made 6 weeks after operation and compared between the CT-based Signature™ procedure and the standard MRI-based Signature™
- Secondary outcome• Fit and practical use of the guides
• Needed change of plans and reasons for changes
• Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components.
• Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg.
• Difference in thickness between the in vivo inserted polyethylene and the pre-operatively calculated thickness of this insert.
• Accurateness of guides: deviations from pre-operative digital plan.
- TimepointsPre-, 6 weeks post and 1 year post operative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsSchotanus, M. G. M., et al. "A radiological analysis of the difference between MRI-and CT-based patient-specific matched guides for total knee arthroplasty from the same manufacturer." Bone Joint J 98.6 (2016): 786-792.
- Brief summary
- Main changes (audit trail)
- RECORD13-aug-2014 - 28-jun-2016


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