Clinical trial NCT02206321: Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels
Official title: Comparison of Navigation and Conventional Total Knee Arthroplasties
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Computer-assisted Navigation Versus Conventional Total Knee Replacement
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients were recruited from the patient undergoing scheduled total knee arthroplasty in our hospitals (Chang Gung Memorial Hospital, Kaohsiung medical center).

Brief summary: 1. Prospective follow-up and comparative analysis of early, midterm, and long-term surgical results and complications between navigation assisted TKA and conventional TKA.
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.

Detailed description: Total knee arthroplasty (TKA) is one of the most successful surgery in orthopaedic field. However, occasional outliner from perfect alignment after prosthesis implantation and unavoidable complications are still concerns. The usage of navigation-assisted system on total knee arthroplasty has provided better accuracy of the component alignment and quantity in knee kinematics, which theoretically affords better and consistent functional outcome.

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.

Eligibility criteria: Inclusion Criteria:

* degenerative osteoarthritis of the knee

Exclusion Criteria:

* autoimmune diseases, rheumatoid arthritis, malignancies, previous knee surgery or post-traumatic arthritis

Primary outcomes:
measure: ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jih-Yang Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.