Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty
NCT ID: NCT01781598
Last Updated: 2013-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2011-09-30
2012-10-31
Brief Summary
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Detailed Description
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The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks \[PMCB\]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant.
This study is a observational monocentric prospective study.
Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment
The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.
As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with Patient specific instruments in TKA
Total knee arthroplasty (TKA) (Smith &Nephew®)
Interventions
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Total knee arthroplasty (TKA) (Smith &Nephew®)
Eligibility Criteria
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Inclusion Criteria
* Genesis II endoprosthesis
* Operated using patient specific instruments (VISIONAIRE)
Exclusion Criteria
* varus/ valgus deformity \>15 degrees
18 Years
ALL
No
Sponsors
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Orthopedic Clinic Gersthof
OTHER
Responsible Party
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Dominik Drnek
Dr. med. univ.
Locations
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Orthopedic Clinic Gersthof
Vienna, , Austria
Countries
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Other Identifiers
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PMCBv1
Identifier Type: -
Identifier Source: org_study_id
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