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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03163888
Enrollment
200
Registered
2017-05-23
Start date
2000-01-01
Completion date
2017-05-01
Last updated
2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Inflammatory Response

Brief 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. 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.

Interventions

PROCEDURENavigation TKR

Traditional over Conventional TKR

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* end stage knee OA necessitating TKR surgeries

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of IL-6(pg/mL)24 hours after TKRserum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

Secondary

MeasureTime frameDescription
Concentration of IL-10(pg/mL)24 hours after TKRserum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
Concentration of TNF-alpha (pg/mL)24 hours after TKRserum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026