Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
18. mai 2014 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
174
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, Korea, Republikken, 463-707
- Rekruttering
- Joint Reconstruction Center, Seoul National University Bundang Hospital
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Ta kontakt med:
- Tae Kyun Kim, MD, PhD
- Telefonnummer: 82-31-787-7196
- E-post: osktk@snubh.org
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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
Andre navn:
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Operation time
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tourniquet time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Forventet)
1. desember 2014
Studiet fullført (Forventet)
1. januar 2015
Datoer for studieregistrering
Først innsendt
20. februar 2013
Først innsendt som oppfylte QC-kriteriene
15. april 2013
Først lagt ut (Anslag)
16. april 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B-1206/158-004
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