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Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01832272
Recruitment Status : Unknown
Verified May 2014 by Tae Kyun Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Reinflation after early tourniquet deflation Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
Study Start Date : February 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: 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).
Procedure: Reinflation after early tourniquet deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Other Name: Reinflation after early tourniquet release

No Intervention: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.



Primary Outcome Measures :
  1. Operation time [ Time Frame: from skin incision to wound closure ]
    Total time between initial skin incision and wound closure


Secondary Outcome Measures :
  1. Tourniquet time [ Time Frame: 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

  2. Difficulty of the operation [ Time Frame: from skin incision to wound closure ]
    Measured by the number of operative field clearance using gauze to make the remained procedure convenient

  3. Incidence of transfusion [ Time Frame: 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

  4. Wound complications [ Time Frame: 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

  5. Thigh complications [ Time Frame: within 2 weeks ]
    Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application

  6. Venous thromboembolism [ Time Frame: within 2 weeks ]
    symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery

  7. Postoperative pain (VAS) [ Time Frame: 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.

  8. More painful site [ Time Frame: 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.

  9. More painful side in SBTKA [ Time Frame: 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.

  10. Amount of drainage [ Time Frame: Until the drainage removal, average of 1 to 2 days after surgery ]
    Total amount of subcutaneous indwelled drainage before removal of it.

  11. Hemoglobin drop on the 2nd day after surgery [ Time Frame: On the 2nd day after surgery ]
    The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value

  12. Hemoglobin drop on the 5th day after surgery [ Time Frame: On the 5th day after surgery ]
    The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832272


Contacts
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Contact: Tae Kyun Kim, MD, PhD 82-31-787-7196 osktk@snubh.org

Locations
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Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital Recruiting
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Tae Kyun Kim, MD, PhD    82-31-787-7196    osktk@snubh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Tae Kyun Kim, MD, PhD Joint Reconstruction Center, Seoul National University Bundang Hospital

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Responsible Party: Tae Kyun Kim, Direcor, Joint reconstruction center, SNUBH, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01832272     History of Changes
Other Study ID Numbers: B-1206/158-004
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Keywords provided by Tae Kyun Kim, Seoul National University Hospital:
Osteoarthritis
Knee
Total knee arthroplasty
Tourniquet
Early release
Reinflation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases