Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02206321
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jih-Yang Ko, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment
Computer-assisted Navigation Versus Conventional Total Knee Replacement Procedure: Navigation total knee arthroplasty Procedure: Conventional total knee arthroplasty

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Navigation and Conventional Total Knee Arthroplasties
Study Start Date : March 2011
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
Navigation total knee arthroplasty
Navigation total knee arthroplasty
Procedure: Navigation total knee arthroplasty
computer assisted navigation total knee arthroplasty without femur intramedullary involvement

Conventional total knee arthroplasty
Conventional total knee arthroplasty
Procedure: Conventional total knee arthroplasty
conventional technique with femur intramedullary violation




Primary Outcome Measures :
  1. ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups [ Time Frame: 24 hours after surgery ]
    We collect the serum and sample from hemovac drainage 24 hours after the surgery, to measure the concentrations of target molecules (ICAM, VCAM, PECAM).


Biospecimen Retention:   Samples With DNA
Obtain the serum and hemovac drainage from the patients, and analyze the concentrations of the markers


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • degenerative osteoarthritis of the knee

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206321


Contacts
Layout table for location contacts
Contact: Jih-Yang Ko, MD 886-7-731-7123 ext 8003 kojy@cgmh.org.tw

Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung city, Taiwan, 833
Contact: Jih-Yang Ko, MD    886-7-731-7123 ext 8003    kojy@cgmh.org.tw   
Principal Investigator: Jih-Yang Ko, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jih-Yang Ko, MD Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jih-Yang Ko, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02206321     History of Changes
Other Study ID Numbers: IRB 100-0038A3
ChangGungMH ( Other Identifier: ChangGungMH )
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017