Arthroplasty ComplicationsNCT03163888
Effects of Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers
An observational study of Arthroplasty Complications and Inflammatory Response, run by Chang Gung Memorial Hospital.
Trial summary
Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for distal femur cutting inevitably violates the medullary canal of femoral bone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty Complications, Inflammatory Response
- What is being tested?
- Navigation TKR
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 May 2017
- 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: Patients necessitating TKA surgery due to advanced degenerative osteoarthritis of the knee visited the outpatient department initially and were then scheduled for admission for TKA surgery. The patients were self-separated into two groups when they visited the outpatient department. The patients visiting professor CJ Wang would undergo conventional TKA, and those visiting Dr. JY Ko would undergo navigation TKA. Both senior authors had performed more than 1,000 TKAs using the conventional and navigation method respectively before recruiting the patients of our study.
Who may be able to join
- end stage knee OA necessitating TKR surgeries
Who cannot join
- autoimmune diseases, malignancies, previous knee surgery or post-traumatic arthritis
About this study
Official title: Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers: A Prospective Comparative Study
Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for distal femur cutting inevitably violates the medullary canal of femoral bone. The process of intramedullary reaming for the insertion of distal femur cutting jigs stimulated the dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or cardiac stress perioperatively. There are emerging refinements aiming to reduce the insult to the medullary canal of the distal femur as well as to improve the prosthetic alignment, such as navigation assisted TKA or robotic surgery.
In addition to better prosthetic alignment, computer-assisted navigation TKAs also mitigate perioperative blood loss and systemic emboli. The publication previously published by the investigators showed that navigation TKAs can lead to lesser extent of elevation of endothelial injury markers than the traditional TKAs. However, the detrimental effects of intramedullary reaming seem to be multi-dimensional and the whole picture has not been elucidated clearly at present.
Read more
Previous studies have shown that operative trauma can trigger marked immune responses. Operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory response, with 80% of the leucocyte transcriptome being affected. Most studies of hip or knee surgery found that operation-triggered immune reactions are associated with postoperative recovery, infection, and even mortality.
The navigation TKAs avoid the process of intra-medullary reaming, which is the mandatory part of conventional TKA for the distal femur cutting. The investigators hypothesize that the reaming process may exert substantial inflammatory response, which can be manifested by higher level of inflammatory markers in the serum and hemovac drainage samples obtained from the participants undergoing conventional TKAs.
- Conditions
- Arthroplasty Complications, Inflammatory Response
- Being tested
- Navigation TKR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation TKRProcedure or surgery
Traditional over Conventional TKR
| Study group | Role | What they receive |
|---|---|---|
| Navigation TKR group | TKR performed under computer navigation without violating distal femur bone marrow. Receives: Procedure: Navigation TKR | |
| Conventional TKR group | TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IL-6(pg/mL)
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
Measured: 24 hours after TKR
Secondary outcomes (2)
Concentration of IL-10(pg/mL)
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
Measured: 24 hours after TKR
Concentration of TNF-alpha (pg/mL)
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
Measured: 24 hours after TKR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jan 2000
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163888
- Sponsor's protocol ID
- 100-0038A3
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03163888
- Acronym / sponsor ID
- 100-0038A3
- Conditions
- Arthroplasty Complications, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 23 May 2017 (actual)
- 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.
Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for distal femur cutting inevitably violates the medullary canal of femoral bone. The process of intramedullary reaming for the insertion of distal femur cutting jigs stimulated the dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or cardiac stress perioperatively. There are emerging refinements aiming to reduce the insult to the medullary canal of the distal femur as well as to improve the prosthetic alignment, such as navigation assisted TKA or robotic surgery.
In addition to better prosthetic alignment, computer-assisted navigation TKAs also mitigate perioperative blood loss and systemic emboli. The publication previously published by the investigators showed that navigation TKAs can lead to lesser extent of elevation of endothelial injury markers than the traditional TKAs. However, the detrimental effects of intramedullary reaming seem to be multi-dimensional and the whole picture has not been elucidated clearly at present.
Previous studies have shown that operative trauma can trigger marked immune responses. Operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory response, with 80% of the leucocyte transcriptome being affected. Most studies of hip or knee surgery found that operation-triggered immune reactions are associated with postoperative recovery, infection, and even mortality.
The navigation TKAs avoid the process of intra-medullary reaming, which is the mandatory part of conventional TKA for the distal femur cutting. The investigators hypothesize that the reaming process may exert substantial inflammatory response, which can be manifested by higher level of inflammatory markers in the serum and hemovac drainage samples obtained from the participants undergoing conventional TKAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation TKR group | – | Procedure: Navigation TKRTKR performed under computer navigation without violating distal femur bone marrow. |
| Conventional TKR group | – | –TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients necessitating TKA surgery due to advanced degenerative osteoarthritis of the knee visited the outpatient department initially and were then scheduled for admission for TKA surgery. The patients were self-separated into two groups when they visited the outpatient department. The patients visiting professor CJ Wang would undergo conventional TKA, and those visiting Dr. JY Ko would undergo navigation TKA. Both senior authors had performed more than 1,000 TKAs using the conventional and navigation method respectively before recruiting the patients of our study.
Key inclusion criteria (1 listed)
- end stage knee OA necessitating TKR surgeries
Key exclusion criteria (1 listed)
- autoimmune diseases, 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 TKRTraditional over Conventional TKR | Procedure or surgery | Navigation TKR group |
Primary outcome
Concentration of IL-6(pg/mL)
Time frame: 24 hours after TKR
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
2 secondary outcomes
Concentration of IL-10(pg/mL)
Time frame: 24 hours after TKR
Concentration of TNF-alpha (pg/mL)
Time frame: 24 hours after TKR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty Complications
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications and Inflammatory Response, run by Chang Gung Memorial Hospital.
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: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of IL-6(pg/mL) (time frame: 24 hours after TKR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2017.