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

21. maj 2017 opdateret af: Chang Gung Memorial Hospital

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

200

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • end stage knee OA necessitating TKR surgeries

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Navigation TKR group
TKR performed under computer navigation without violating distal femur bone marrow.
Traditional over Conventional TKR
Conventional TKR group
TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concentration of IL-6(pg/mL)
Tidsramme: 24 hours after TKR
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
24 hours after TKR

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concentration of IL-10(pg/mL)
Tidsramme: 24 hours after TKR
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)
Tidsramme: 24 hours after TKR
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
24 hours after TKR

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2000

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. maj 2017

Datoer for studieregistrering

Først indsendt

11. maj 2017

Først indsendt, der opfyldte QC-kriterier

21. maj 2017

Først opslået (Faktiske)

23. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 100-0038A3

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Inflammatorisk respons

Kliniske forsøg med Navigation TKR

3
Abonner