|- candidate number||19289|
|- NTR Number||NTR4734|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-aug-2014|
|- Secondary IDs||13T174 |
|- Public Title||Radiological evaluation of CT vs MRI based Signature™ for total knee arthroplasty
A Prospective, Randomized Study
|- Scientific Title||CT vs MRI based Signature™ for TKA|
|- ACRONYM||CT, 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) studied||Total 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
- 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2014|
|- planned closingdate||1-jan-2015|
|- Target number of participants||140|
|- Interventions||TKA 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.
|- Timepoints||Pre-, 6 weeks post and 1 year post operative|
|- Trial web site|
|- 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|
(Source(s) of Monetary or Material Support)
|- Publications||Schotanus, 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)|
|- RECORD||13-aug-2014 - 28-jun-2016|