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Comparison between CT- and MRI-based Patient specific matched instruments for total knee arthroplasty


- candidate number15288
- NTR NumberNTR4122
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2013
- Secondary IDs13N104 METC azM/UM / METC Atrium-Orbis-Zuyd
- Public TitleComparison between CT- and MRI-based Patient specific matched instruments for total knee arthroplasty
- Scientific TitleIs there difference between CT- and MRI-based Patient specific matched instruments for total knee arthroplasty
- ACRONYMCT and MRI based matched instruments
- hypothesisThere is no difference between CT- and MRI-based Patient specific matched instruments for total knee arthroplasty
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Knee osteoarhritis, MRI, Computed tomography
- Inclusion criteriapatients operated for unilateral total knee arthroplasty (TKA) with the use of patient specific matched instruments (PSMI
- Exclusion criteriaNA
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate31-okt-2013
- Target number of participants92
- InterventionsPatient specific matched instruments (PSMI) for total knee arthroplasty (TKA) is a new and upcoming technique that uses 3D rapid prototyped disposable guides to align the knee prosthesis. This case control study will review a cohort (n= 899 cases) of patients operated for unilateral total knee arthroplasty (TKA) with the use of patient specific matched instruments (PSMI; Signature, Biomet, Warsaw INC). This PSMI utilizes CT or MR imaging. Patients operated for TKA who were not eligible to undergo MRI and were operated by means of CT-based PSMI will be included. These patients will be adequately matched on gender, age and body mass index (BMI) with a group of patients operated with MRI-based PSMI (Control group) out of the cohort.
- Primary outcomeBiomechanical limb alignment, femoral and tibial component position
- Secondary outcomeAll patients are operated with PSMI. The operating surgeon reviewed all the pre operative digital plans and had the ability to change the default settings provided from the software. Per operative changes of the approved size of the planned femoral and tibial component are noted if approved pre operative planning changed. Mean operation time (incision to closure in minutes) and blood loss (in ml) will be obtained from the operative record.
- TimepointsPrimary outcome, biomechanical limb alignment, femoral and tibial component position were evaluated on 1 year post operative standardized full leg standing radiographs and sagital plane radiographs
- Trial web siteNA
- statusopen: patient inclusion
- 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
- PublicationsAccuracy of CT-based patient specific guides for total knee arthroplasty in patients with post-traumatic osteoarthritis and retained metal hardware around the knee joint from previous surgery. M.G.M. Schotanus, E.H. van Haaren, R.P.M. Hendrickx, E.J.P. Jansen, N.P. Kort Eur J Orthop Surg Traumatol. 2015 Aug 12
- Brief summaryPatient specific matched instruments (PSMI) can be used to align total knee arthroplasty. This technique utilizes CT and MR imaging. The present study is designed to investigate postoperative radiographs, pre operative planning and per operative outcome between CT and MRI based PSMI
- Main changes (audit trail)
- RECORD19-aug-2013 - 18-aug-2015


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