Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels
NCT ID: NCT02206321
Last Updated: 2017-02-06
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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UNKNOWN
100 participants
OBSERVATIONAL
2011-03-31
2019-12-31
Brief Summary
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2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from blood, tissues, and drainage between navigation assisted TKA and conventional TKA.
3. Prospective follow-up of surgical results of navigation-assisted TKA.
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Detailed Description
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In addition to better alignment, the design of navigation system avoids violation of the medullary canal. This less invasive environment might be contributable to the less blood loss in the drainage bottle, less blood transfusion more stable hemodynamic status, fewer hospitalization days, and fewer complications.
Systemic emboli phenomena during preparation of the femur and tibia are well recognized during total knee arthroplasty. They are widely believed to be the cause of intraoperative hypotension and reduced cardiac output, which may lead to circulatory collapse, change of mental status or cerebral infarction. Kalairajah et al reported that navigation-assisted total knee arthroplasty, when compared with conventional jig-based surgery, significantly reduces systemic emboli as detected by transcranial Doppler ultrasonography. Church et al undertook a prospective, double-blind, randomized study to compare the cardiac emboli load by tranesophageal echocardiography and demonstrated that computer-assisted TKA resulted in the release of significant fewer systemic emboli than the conventional procedure using intramedullary alignment. The increased blood loss in conventional TKA may be due to intramedullary jigging of both femur and tibia, bleeding from sinusoids at the cut cancellous bone surfaces with continuous suction drainage and more soft tissue dissection during balancing of the prosthesis. The investigators have underwent more than 730 computer-assisted TKA since 2005. The investigators data shows less bleeding and fewer transfusion after navigation assisted TKA. The investigators wish to further follow-up and delineate the differential clinical outcomes and perioperative markers (including ICAM, VCAM, and PECAM and other cytokines )between computer-assisted TKA and conventional TKA.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Navigation total knee arthroplasty
Navigation total knee arthroplasty
Navigation total knee arthroplasty
computer assisted navigation total knee arthroplasty without femur intramedullary involvement
Conventional total knee arthroplasty
Conventional total knee arthroplasty
Conventional total knee arthroplasty
conventional technique with femur intramedullary violation
Interventions
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Navigation total knee arthroplasty
computer assisted navigation total knee arthroplasty without femur intramedullary involvement
Conventional total knee arthroplasty
conventional technique with femur intramedullary violation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Jih-Yang Ko
Professor
Principal Investigators
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Jih-Yang Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Kuo SJ, Wang FS, Wang CJ, Ko JY, Chen SH, Siu KK. Effects of Computer Navigation versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels: A Prospective Comparative Study. PLoS One. 2015 May 8;10(5):e0126663. doi: 10.1371/journal.pone.0126663. eCollection 2015.
Other Identifiers
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ChangGungMH
Identifier Type: OTHER
Identifier Source: secondary_id
IRB 100-0038A3
Identifier Type: -
Identifier Source: org_study_id
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