Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels
Comparison of Navigation and Conventional Total Knee Arthroplasties
2 other identifiers
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 6, 2017
February 1, 2017
8.8 years
July 29, 2014
February 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups
We collect the serum and sample from hemovac drainage 24 hours after the surgery, to measure the concentrations of target molecules (ICAM, VCAM, PECAM).
24 hours after surgery
Study Arms (2)
Navigation total knee arthroplasty
Navigation total knee arthroplasty
Conventional total knee arthroplasty
Conventional total knee arthroplasty
Interventions
computer assisted navigation total knee arthroplasty without femur intramedullary involvement
conventional technique with femur intramedullary violation
Eligibility Criteria
All the patients were recruited from the patient undergoing scheduled total knee arthroplasty in our hospitals (Chang Gung Memorial Hospital, Kaohsiung medical center).
You may qualify if:
- degenerative osteoarthritis of the knee
You may not qualify if:
- autoimmune diseases, rheumatoid arthritis, malignancies, previous knee surgery or post-traumatic arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Related Publications (1)
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.
PMID: 25955252DERIVED
Biospecimen
Obtain the serum and hemovac drainage from the patients, and analyze the concentrations of the markers
Study Officials
- PRINCIPAL INVESTIGATOR
Jih-Yang Ko, MD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 29, 2014
First Posted
August 1, 2014
Study Start
March 1, 2011
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 6, 2017
Record last verified: 2017-02