Effects of Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers: A Prospective Comparative Study

Conditions
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Arthroplasty Complications, Inflammatory Response

Intervention / Treatment
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* Procedure: Navigation TKR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: end stage knee OA necessitating TKR surgeries Exclusion Criteria: autoimmune diseases, malignancies, previous knee surgery or post-traumatic arthritis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Navigation TKR group<br>TKR performed under computer navigation without violating distal femur bone marrow. | Procedure: Navigation TKR<br>* Traditional over Conventional TKR<br>|
| Conventional TKR group<br>TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of IL-6(pg/mL) | serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR | 24 hours after TKR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of IL-10(pg/mL) | serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR | 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 | 24 hours after TKR |