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OpenTrials
Completed

NCT Number: NCT03163888

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • end stage knee OA necessitating TKR surgeries

Exclusion criteria

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

Treatment and study plan

Navigation TKR

Procedure

Traditional over Conventional TKR

Primary outcomes

  1. 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

Secondary outcomes

  1. Concentration of IL-10(pg/mL)

    Time frame: 24 hours after TKR

    serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

  2. Concentration of TNF-alpha (pg/mL)

    Time frame: 24 hours after TKR

    serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2017
Study completion
2017
First posted
May 23, 2017
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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