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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01832272
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
Intervento / Trattamento
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
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, Corea, Repubblica di, 463-707
- Reclutamento
- Joint Reconstruction Center, Seoul National University Bundang Hospital
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Contatto:
- Tae Kyun Kim, MD, PhD
- Numero di telefono: 82-31-787-7196
- Email: osktk@snubh.org
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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 |
|---|---|
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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).
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The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Altri nomi:
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Nessun intervento: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Operation time
Lasso di tempo: from skin incision to wound closure
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Total time between initial skin incision and wound closure
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from skin incision to wound closure
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Tourniquet time
Lasso di tempo: total sum of time between inflation and deflation of tourniquet
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Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
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total sum of time between inflation and deflation of tourniquet
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Difficulty of the operation
Lasso di tempo: from skin incision to wound closure
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Measured by the number of operative field clearance using gauze to make the remained procedure convenient
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from skin incision to wound closure
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Incidence of transfusion
Lasso di tempo: within 2weeks after surgery
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The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
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within 2weeks after surgery
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Wound complications
Lasso di tempo: on the 2nd and 14th day after surgery
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wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
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on the 2nd and 14th day after surgery
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Thigh complications
Lasso di tempo: within 2 weeks
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Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
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within 2 weeks
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Venous thromboembolism
Lasso di tempo: within 2 weeks
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symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
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within 2 weeks
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Postoperative pain (VAS)
Lasso di tempo: on the 2nd and 5th day after surgery.
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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.
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on the 2nd and 5th day after surgery.
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More painful site
Lasso di tempo: on the 2nd and 5th day after surgery
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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.
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on the 2nd and 5th day after surgery
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More painful side in SBTKA
Lasso di tempo: on the 2nd and 5th day after surgery.
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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.
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on the 2nd and 5th day after surgery.
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Amount of drainage
Lasso di tempo: Until the drainage removal, average of 1 to 2 days after surgery
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Total amount of subcutaneous indwelled drainage before removal of it.
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Until the drainage removal, average of 1 to 2 days after surgery
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Hemoglobin drop on the 2nd day after surgery
Lasso di tempo: On the 2nd day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
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On the 2nd day after surgery
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Hemoglobin drop on the 5th day after surgery
Lasso di tempo: On the 5th day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
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On the 5th day after surgery
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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
Termini MeSH pertinenti aggiuntivi
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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