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Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

18 maggio 2014 aggiornato da: Tae Kyun Kim, Seoul National University Hospital

The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

174

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Gyeonggi-do
      • Seongnam-Si, Gyeonggi-do, Corea, Repubblica di, 463-707
        • Reclutamento
        • Joint Reconstruction Center, Seoul National University Bundang Hospital
        • Contatto:
          • Tae Kyun Kim, MD, PhD
          • Numero di telefono: 82-31-787-7196
          • Email: osktk@snubh.org

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of primary osteoarthritis of the knee
  • Scheduled for elective total knee arthroplasty
  • Written signed consent

Exclusion Criteria:

  • Revision TKA
  • Diagnosis other than primary osteoarthritis
  • Intra-articular indwelling drainage
  • Refusing participate

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Reinflation after early deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Altri nomi:
  • Reinflation after early tourniquet release
Nessun intervento: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Operation time
Lasso di tempo: from skin incision to wound closure
Total time between initial skin incision and wound closure
from skin incision to wound closure

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tourniquet time
Lasso di tempo: total sum of time between inflation and deflation of tourniquet
Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
total sum of time between inflation and deflation of tourniquet
Difficulty of the operation
Lasso di tempo: from skin incision to wound closure
Measured by the number of operative field clearance using gauze to make the remained procedure convenient
from skin incision to wound closure
Incidence of transfusion
Lasso di tempo: within 2weeks after surgery
The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
within 2weeks after surgery
Wound complications
Lasso di tempo: on the 2nd and 14th day after surgery
wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
on the 2nd and 14th day after surgery
Thigh complications
Lasso di tempo: within 2 weeks
Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
within 2 weeks
Venous thromboembolism
Lasso di tempo: within 2 weeks
symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
within 2 weeks
Postoperative pain (VAS)
Lasso di tempo: on the 2nd and 5th day after surgery.
An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
on the 2nd and 5th day after surgery.
More painful site
Lasso di tempo: on the 2nd and 5th day after surgery
An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
on the 2nd and 5th day after surgery
More painful side in SBTKA
Lasso di tempo: on the 2nd and 5th day after surgery.
An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
on the 2nd and 5th day after surgery.
Amount of drainage
Lasso di tempo: Until the drainage removal, average of 1 to 2 days after surgery
Total amount of subcutaneous indwelled drainage before removal of it.
Until the drainage removal, average of 1 to 2 days after surgery
Hemoglobin drop on the 2nd day after surgery
Lasso di tempo: On the 2nd day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
On the 2nd day after surgery
Hemoglobin drop on the 5th day after surgery
Lasso di tempo: On the 5th day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
On the 5th day after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2013

Completamento primario (Anticipato)

1 dicembre 2014

Completamento dello studio (Anticipato)

1 gennaio 2015

Date di iscrizione allo studio

Primo inviato

20 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

15 aprile 2013

Primo Inserito (Stima)

16 aprile 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • B-1206/158-004

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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