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

NCT ID: NCT03163888

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-01
• Study Completion Date: 2017-05-01

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.

Conditions

Arthroplasty Complications; Inflammatory Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Navigation TKR group

TKR performed under computer navigation without violating distal femur bone marrow.

Navigation TKR

Intervention Type: PROCEDURE

Traditional over Conventional TKR

Conventional TKR group

TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow.

No interventions assigned to this group

Interventions

Navigation TKR

Traditional over Conventional TKR

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• end stage knee OA necessitating TKR surgeries

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

100-0038A3

Identifier Type: -

Identifier Source: org_study_id