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

Completed

• Conditions: Inflammatory Response; Arthroplasty Complications
• Interventions: Procedure: Navigation TKR

• Registration Number: NCT03163888
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Status Verified: 2017-05
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-21
• Last Update Submitted: 2017-05-21
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• end stage knee OA necessitating TKR surgeries

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Navigation TKR group	Navigation TKR	TKR performed under computer navigation without violating distal femur bone marrow.

Primary Outcome Measures

Name	Time	Method
Concentration of IL-6(pg/mL)	24 hours after TKR	serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

Secondary Outcome Measures

Name	Time	Method
Concentration of IL-10(pg/mL)	24 hours after TKR	serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
Concentration of TNF-alpha (pg/mL)	24 hours after TKR	serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR