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van CCT (UK)

van CCT (UK)

Accuracy of Patient Specific Guides for Revision of unicompartmental knee arthroplasty to total knee arthroplasty.

- candidate number24301
- NTR NumberNTR5835
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-apr-2016
- Secondary IDsMETC 16N96  
- Public TitleAccuracy of Patient Specific Guides for Revision of unicompartmental knee arthroplasty to total knee arthroplasty.
- Scientific TitlePatient Specific Guides for Revision of unicompartmental knee arthroplasty comparing preoperatively planned alignment with postoperatively achieved
- hypothesisThe hypothesis of this study was that the Oxord UKA will not hamper the accuracy of the CT-based PSG for TKA during revision surgery to restore biomechanical limb alignment and prosthetic component positioning as calculated by the software and the actual alignment in vivo after knee surgery with limited percentages of outliers.
- Healt Condition(s) or Problem(s) studiedKnee, Arthroplasty , Patient specific
- Inclusion criteriaPatients initiated for revision of the Oxford implant.
- Exclusion criterian.a.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-jul-2016
- Target number of participants10
- InterventionsPre-operative CT-scanning of the hip, knee and ankle was performed 6 weeks prior to surgery according to the standard Signature scanning protocol. Software (Mimics, Materialise NV, Leuven, Belgium) was used to create virtual three-dimensional models of femur and tibia. The program was used to determine appropriate implant size and positioning of the knee prosthesis (Vanguardô Complete Knee System, Biomet, Inc., Warsaw, IN) for each patient individually. A digital, virtual plan of the proposed perioperative positioning was sent to the surgeon. The surgeon was able to adjust the digital plan when deemed necessary. After approving the digital plan, guides for perioperative use were manufactured using a rapid prototype engineering technique. Intraoperatively, the practical form and fit of the guides and all perioperative changes from the pre-operative plan (level of resection, size of prosthesis) are registered in the patients digital operative record.
- Primary outcomeAngular component position and absolute deviations of angular component position in three planes from pre-op planning will be determined as well as translational component position along the three axes of the bone and absolute deviations of the planned translational component position.
- Secondary outcomePROMs were obtained pre- and 12 months postoperative including the Dutch validated Oxford Knee Score (OKS; 12 to 60, 12 being the best outcome), Western Ontario and McMaster Universities Arthritis Index (WOMAC; 0 to 100, 100 being the best outcome) and the EuroQol-5D (EQ-5D; 0 to 1, 1 indicates the best health state). Experienced pain was measured by a Numerical Rating Scale (NRS, 0 to 10, 10 being Ďworst painí).
- Timepointsn.a.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIn het Zuyderland Medisch Centrum, voorheen Orbis MC zijn tussen oktober 2010 en oktober 2014, 22 halve knie prothese gereviseerd naar een totale knie prothese middels de Signature techniek. In de literatuur zijn er weinig tot geen duidelijke gegevens over deze techniek m.b.t. revisies met Signature. Doormiddel van dit onderzoek willen wij gaan kijken naar de accuraatheid van deze operatie techniek. Er wordt primair gekeken naar de uitlijning van de prothese en secundair naar de kliniek en het functioneren van de patiŽnten in het dagelijkse leven. Dit willen wij gaan bereiken door de gegevens uit de digitale patiŽnten dossiers te halen, de vragenlijsten en het radiologische onderzoek te analyseren.. Gezien het retrospectieve karakter van het onderzoek, zijn wij van mening dat het een niet WMO plichtig onderzoek is waarbij patiŽnten op geen enkele manier belast zullen worden.
- Main changes (audit trail)
- RECORD26-apr-2016 - 22-jun-2016

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