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2Y-FU-PSI-UKA


- candidate number26664
- NTR NumberNTR6436
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2017
- Secondary IDs16-N-106 METC
- Public Title2Y-FU-PSI-UKA
- Scientific Title2 Years Follow-up of patient-specific matched instruments for unicompartmental knee arthroplasty A prospective cohort study
- ACRONYMPSI-UKA
- hypothesisWe hypothesize that there is no difference in clinical and radiological outcome when using PSG for UKA compared with results from the literature describing results from conventional UKA surgical techniques.
- Healt Condition(s) or Problem(s) studiedKnee arthroplasty
- Inclusion criteria Patients who received UKA using PSG
Patients who complete the preoperative and follow-up at 3 months, 1 and 2-years
Patients of whom digital radiographs are available
- Exclusion criteria Patients who failed to complete follow-up
Patients of whom no digital radiographs are available
Patients of whom digital radiographs are of poor quality
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-sep-2017
- Target number of participants120
- InterventionsA relatively new technique for the perioperative alignment of prosthesis components inunicompartmental knee arthroplasty (UKA) is the use of patient-specific guiding (PSG). The guides used in this technique are made of synthetic material, custom-made using MR imaging to fit anatomical landmarks of femur and tibia of a certain patient. These guides assist the surgeon in placing the implant in an anatomic fashion. Precision in implant placement restores biomechanics of the knee joint and should increase longevity of the prosthesis
- Primary outcomeImplant alignment and survival
- Secondary outcomePROMs
- Timepointspreoperative and follow-up at 3 months, 1 and 2-years
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRecently, patient-specific guiding (PSG) was introduced in total knee arthroplasty (TKA) and UKA. It is believed but not yet proven that this technique aids in improvement of prosthesis position but also in decreasing operation time and decreasing blood loss. However, limited literature is present on PSG in UKA
- Main changes (audit trail)
- RECORD9-feb-2017 - 29-jun-2017


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