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The influence of computer navigation on prosthesis position in revision total knee arthroplasty.


- candidate number13111
- NTR NumberNTR3512
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2012
- Secondary IDs2012/220 METC UMCG
- Public TitleThe influence of computer navigation on prosthesis position in revision total knee arthroplasty.
- Scientific TitleThe influence of computer assisted surgery on coronal, sagittal and rotational alignment in revision total knee arthroplasty.
- ACRONYM
- hypothesisDespite good results of primary total knee arthroplasty (TKA) the number of revision total knee arthroplasties (rTKAs) is rising and a further increase is predicted. rTKA is a more complicated surgical procedure compared to primary TKA and leads to worse clinical results. In primary TKA, one can identify anatomical landmarks and use these for determining the position of the implant using mechanical navigation guides. However, in rTKA most of the time anatomical landmarks have disappeared because of extensive bone loss, making it more difficult to adequately implant the prosthesis. Proper positioning of the implant is very important, since malpositioning of the implant leads to worse patient outcome. In primary TKA, computer assisted surgery (CAS) leads to better prosthesis alignment compared to mechanical alignment guides and it is hypothesized that the use of CAS will have the same effect in rTKA. However, this is not well investigated. Objective of this study is therefore to investigate prosthesis alignment when using CAS in rTKA. Our hypothesis is that CAS leads to a more accurate rotational, coronal and sagittal prosthesis alignment when used in rTKA.
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Computer navigation
- Inclusion criteriaInclusion criteria for the intervention group are:
1. The use of CAS during rTKA;
2. A minimum age of 18 years;
3. Only total revisions, re-implantations and partial revisions of either the tibial or femoral part are included. For partial revisions, only measurements of the part of the prosthesis which will be revised will be used.

Inclusion criteria for the historical control group are:
1. rTKA without the use of CAS;
2. A minimum age of 18 years;
3. Only total revisions, re-implantations and partial revisions of either the tibial or femoral part are included. For partial revisions, only measurements of the part of the prosthesis which is revised will be used;
4. Patients will only be included if a type of prosthesis was implanted which is still used nowadays.
- Exclusion criteriaExclusion criteria for both groups are:
1. Partial revisions without total revision of the tibial or femoral part;
2. Patients who received or will receive a tumor prosthesis;
3. Patients with a limited knowledge of the Dutch language or who are mentally incapable for participation.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-sep-2015
- Target number of participants88
- InterventionsIn the intervention group, CAS will be admitted to rTKA to determine the position of the revision prosthesis. We will use the ORTHOsoft Navitrack® navigation system from Zimmer. The navigation is based on an infrared reflecting system with use of trackers in femur and tibia. The system guides the operation by an image-free model based on anatomical landmarks handed by the surgeon.

In the control group the position of the revision prosthesis was determined using an intramedullary alignment system for femur and tibia.

A prospective clinical intervention study with use of a historical control group will be conducted. In the prospective intervention group patients will undergo rTKA using CAS. These operations will take place between September 2012 and September 2015. The historical control group will consist of patients who underwent a rTKA between January 2002 and April 2012 (Ntotaal=165). In the historical control group patients were operated without the use of CAS. Both groups will be matched according to gender. For every patient in the interventiongroup, a patient of the same gender will be searched for participation in the historic control group. Rotational prosthesis alignment will be compared when measured using a CT-scan of the operated leg and alignment in coronal and sagittal plane will be compared when measured using EOS images.
- Primary outcomeRotational alignment.
- Secondary outcomeAlignment in coronal and sagittal plane.
- TimepointsPostoperative anterior-posterior and lateral X-ray and CT-scan will be performed. No specific timepoint exists.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marrigje F. Meijer
- CONTACT for SCIENTIFIC QUERIES Marrigje F. Meijer
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryBackground:
Despite good results of primary total knee arthroplasty (TKA) the number of revision total knee arthroplasties (rTKAs) is rising and a further increase is predicted. rTKA is a more complicated surgical procedure compared to primary TKA and leads to worse clinical results. In primary TKA, one can identify anatomical landmarks and use these for determining the position of the implant using mechanical navigation guides. However, in rTKA most of the time anatomical landmarks have disappeared because of extensive bone loss, making it more difficult to adequately implant the prosthesis. Proper positioning of the implant is very important, since malpositioning of the implant leads to worse patient outcome. In primary TKA, computer assisted surgery (CAS) leads to better prosthesis alignment compared to mechanical alignment guides and it is hypothesized that the use of CAS will have the same effect in rTKA. However, this is not well investigated. Objective of this study is therefore to investigate prosthesis alignment when using CAS in rTKA and it is our hypothesis is that CAS leads to more accurate prosthesis alignment.
Primary objective is rotational prosthesis alignment and secondary objective is prosthesi alignment in coronal and sagittal plane.

Material and methods:
A prospective clinical intervention study with use of a historical control group will be conducted. Fortyfour patients with a minimum age of 18 years who will be admitted for CAS - rTKA between September 2012 and September 2015 will be included in the intervention group. Fortyfour patients with a minimum age of 18 years who were admitted for rTKA between January 2002 and April 2012 with the use of a conventional operation technique will form the historical control group. Both groups will be matched according to gender. In the intervention group, CAS will be used to determine prosthesis position during rTKA and in the historical control group a intramedullary mechanical alignment guide is used. Discussion: Several studies show a significantly positive influence of CAS on prosthesis alignment in primary TKA, but literature about the use of CAS in rTKA is limited. Purpose of this study is to investigate the influence of CAS during rTKA on postoperative prosthesis alignment, compared to a conventional operation technique.
- Main changes (audit trail)
- RECORD6-jul-2012 - 15-jul-2012


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