search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Is there difference of the pre operative planning of the total knee arthroplasty between orthopedic surgeons?


- candidate number15292
- NTR NumberNTR4127
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2013
- Secondary IDs13N107 and 13N108 METC Atrium-Orbis-Zuyd
- Public TitleIs there difference of the pre operative planning of the total knee arthroplasty between orthopedic surgeons?
- Scientific TitleValidity and reliability of pre operative TKA planning between orthopedic surgeons?
- ACRONYMTKA
- hypothesisWe hypothesise that there would be no significant difference between the preoperative planning between different orthopedic surgeons.
- Healt Condition(s) or Problem(s) studiedPre-operative, Planning, Validation, TKA, Reliability, Inter class correlation
- Inclusion criteriaPre operative planned TKA of patients with PSMI
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate31-dec-2012
- Target number of participants75
- InterventionsFifty cases will be random selected from the total cohort. The planning of these cases will be evaluated by 10 international orthopedic surgeons experienced with patient matched instruments. No patients are involved, only the pre operative plan of patients will be used.
Based on 50 plans for each surgeon, inter observer variability will be calculated

Twenty five cases will be random selected from the total cohort. The planning of these cases will be evaluated by 4 orthopedic surgeons. Each case will be planned for 3 times by each surgeon. Surgeons in Orbis Medisch Centrum will participate in this study. No patients are involved, only the pre operative plan of operated patients will be used.
Based on 3 plans for each case, intra-observer variability will be calculated
Based on 25 plans for each surgeon, inter observer variability will be calculated
- Primary outcomeChanges to the plan, the surgeon can modify the settings for femur and tibia alignment.
- Secondary outcomeThe surgeon is also able to change the size for femur or tibia implant.
- TimepointsN/A
- 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 summaryTo our knowledge, no studies have yet been conducted comparing the pre-operative planning of patients between orthopedic surgeons, experienced with patient specific matched instruments. This study is designed to address the following research question: is there a significant difference between the alignment of the individual femoral and tibial components as planned.
- Main changes (audit trail)
- RECORD19-aug-2013 - 2-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl