Computer-assisted Navigation Versus Conventional Total Knee ReplacementNCT02206321
Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels
An observational study of Computer-assisted Navigation Versus Conventional Total Knee Replacement, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Computer-assisted Navigation Versus Conventional Total Knee Replacement
- What is being tested?
- Navigation total knee arthroplasty and Conventional total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- degenerative osteoarthritis of the knee
Who cannot join
- autoimmune diseases, rheumatoid arthritis, malignancies, previous knee surgery or post-traumatic arthritis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kaohsiung City, 833
Jih-Yang Ko, MD, 886-7-731-7123 ext. 8003, kojy@cgmh.org.tw
Jih-Yang Ko, MD
About this study
Official title: Comparison of Navigation and Conventional Total Knee Arthroplasties
- Prospective follow-up and comparative analysis of early, midterm, and long-term surgical results and complications between navigation assisted TKA and conventional TKA.
- Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from blood, tissues, and drainage between navigation assisted TKA and conventional TKA.
- Prospective follow-up of surgical results of navigation-assisted TKA.
Read the 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.
- Being tested
- Navigation total knee arthroplasty, Conventional total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation total knee arthroplastyProcedure or surgery
computer assisted navigation total knee arthroplasty without femur intramedullary involvement
Conventional total knee arthroplastyProcedure or surgery
conventional technique with femur intramedullary violation
| Study group | Role | What they receive |
|---|---|---|
| Navigation total knee arthroplasty | Navigation total knee arthroplasty Receives: Procedure: Navigation total knee arthroplasty | |
| Conventional total knee arthroplasty | Conventional total knee arthroplasty Receives: Procedure: Conventional total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMar 2011
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Computer-assisted Navigation Versus Conventional Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jih-Yang Ko, Chang Gung Memorial Hospital
- Investigators
- Jih-Yang Ko, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206321
- Sponsor's protocol ID
- IRB 100-0038A3
- Other IDs
- ChangGungMH
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25955252
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Navigation and Conventional Total Knee Arthroplasties
- ClinicalTrials.gov ID
- NCT02206321
- Acronym / sponsor ID
- IRB 100-0038A3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Prospective follow-up and comparative analysis of early, midterm, and long-term surgical results and complications between navigation assisted TKA and conventional TKA.
- Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from blood, tissues, and drainage between navigation assisted TKA and conventional TKA.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation total knee arthroplasty | – | Procedure: Navigation total knee arthroplastyNavigation total knee arthroplasty |
| Conventional total knee arthroplasty | – | Procedure: Conventional total knee arthroplastyConventional total knee arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- degenerative osteoarthritis of the knee
Key exclusion criteria (1 listed)
- autoimmune diseases, rheumatoid arthritis, malignancies, previous knee surgery or post-traumatic arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation total knee arthroplastycomputer assisted navigation total knee arthroplasty without femur intramedullary involvement | Procedure or surgery | Navigation total knee arthroplasty |
| Conventional total knee arthroplastyconventional technique with femur intramedullary violation | Procedure or surgery | Conventional total knee arthroplasty |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 25955252Kuo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jih-Yang Ko, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Computer-assisted Navigation Versus Conventional Total Knee Replacement, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jih-Yang Ko, MD (886-7-731-7123 ext. 8003, kojy@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.