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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Response; Arthroplasty Complications
• Intervention / Treatment: Procedure: Navigation TKR

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients necessitating TKA surgery due to advanced degenerative osteoarthritis of the knee visited the outpatient department initially and were then scheduled for admission for TKA surgery. The patients were self-separated into two groups when they visited the outpatient department. The patients visiting professor CJ Wang would undergo conventional TKA, and those visiting Dr. JY Ko would undergo navigation TKA. Both senior authors had performed more than 1,000 TKAs using the conventional and navigation method respectively before recruiting the patients of our study.

Description

Inclusion Criteria:

• end stage knee OA necessitating TKR surgeries

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Navigation TKR group; TKR performed under computer navigation without violating distal femur bone marrow.	Procedure: Navigation TKR; Traditional over Conventional TKR
Conventional TKR group; TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 100-0038A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No