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A Study on the Use of Tourniquet Use In Primary Total Knee Arthroplasty

Primary Purpose

Osteo Arthritis Knee, Rheumatoid Arthritis of Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tourniquet
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteo Arthritis Knee focused on measuring Tourniquet, Total Knee Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients suffer from primary osteoarthritis indicated for total knee arthroplasty
  2. Subject is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
  3. Subject must have signed an informed consent document specific to the study, and approved by the Ethics Committee, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  1. Subject requires a revision knee arthroplasty surgery
  2. Subject is currently on anti-coagulant therapy or has coagulopathy
  3. Subject has peripheral vascular disease of the lower limb evidenced by the presence of blood vessel calcification on the radiographs or the absence of dorsalis pedis/popliteal pulses
  4. Subject suffers from conditions other than primary knee osteoarthritis, e.g. inflammatory arthritis
  5. Subject having associated medical diseases affecting rehabilitation
  6. Subject has active systemic infection or infection near the knee joint
  7. Subject having current medical condition that render them unfit for surgery
  8. Any criterion which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Cement only

    Skin to Cement

    Skin to Skin

    Arm Description

    The tourniquet was inflated just before cement application and deflated after its hardening

    Inflation of tourniquet before skin incision and its deflation after hardening of cement

    Inflate of tourniquet before incision and deflate following completion of skin closure

    Outcomes

    Primary Outcome Measures

    Blood Loss
    We calculated the intraoperative blood loss by measuring the suction volume and weighing the sponges. Hemoglobin (Hb) and hematocrit (Hct) levels were examined preoperatively, and on Day 1 to Day 4 after surgery. Change of Hb and Hct was calculated as the value of postoperative D1 to D4 minus preoperative value. The number of patients undergoing blood transfusion were recorded. The criterion for a blood transfusion was set as a Hb level of <8 g/dL with symptomatic anemia. The calculated blood loss, which reflects actual blood loss, was determined with use of a previously described method. Briefly, the patients blood volume (PBV) is calculated using a formula, and multiplying the PBV by the change of haematocrit (preoperative value minus value on postoperative Day 2) will give the estimated total blood loss (ETBL).

    Secondary Outcome Measures

    Soft-tissue damage
    We assessed soft-tissue damage by examining serum C-reactive protein (CRP), creatine kinase (CK), lactate dehydrogenase (LDH), and interleukin-6 (IL-6) levels preoperatively and on postoperative days 1, 2, 3 and 4
    Thigh circumference
    Thigh circumference was measured 10 cm proximal to the patella and leg circumference was measured 15 cm distal to the patella, to determine the degree of swelling, and was measured on postoperative days 1, 2, 3 and 4. X-rays were taken after surgery to measure the lower limb alignment, and tibial and femoral components position.
    Postoperative Visual Analog Scale
    Postoperative visual analog scale (VAS) scores were obtained for both knee and thigh pain preoperatively and on postoperative.
    Peak Quadriceps Strength
    The strength of each leg was evaluated by using an isokinetic dynamometer. Peak torque measured in both the concentric and eccentric modes.
    Time-up-and-go (TUG) Test
    he TUG test was used to evaluate the preoperative degree of mobility. This test involves measuring the time a patient needs to get up from a chair, walk three meters, turn, walk back to the chair and then sit down again.
    6-minute Walking Test
    A test that evaluates the functional capacity of the patient while walking on a flat, hard surface in the 6-minute window. It assess all the systems that are involved in the 6-minute window.
    Berg Balance Scale
    The BBS test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
    Knee Society Knee Score
    A knee score that rates only the knee joint itself, there are three main parameters which are pain, stability and the range of motion. Whereas flexion contracture, extension lag and misalignment would be different ways for point deductions. 100 points would refer to a patient with no knee pain, 125 degree range of motion and negligible anteroposterior and mediolateral instability.
    Knee Society Function Score
    A functional score that rates the patient's ability to walk and climb stairs, points would be deducted if the patient uses any walking aids for the two. 100 points would refer to a patient that can walk for an unlimited distance and go up and down the stairs without any trouble.

    Full Information

    First Posted
    July 14, 2020
    Last Updated
    August 4, 2020
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04502459
    Brief Title
    A Study on the Use of Tourniquet Use In Primary Total Knee Arthroplasty
    Official Title
    A Prospective Randomized Trial on the Use of Tourniquet in Primary Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 5, 2015 (Actual)
    Primary Completion Date
    December 15, 2017 (Actual)
    Study Completion Date
    December 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the associated risks include skin burns, soft tissue and muscle damage, injury of calcified vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and thromboembolic events. The automatic lower limb pneumatic tourniquet system (Zimmer) was applied to reduce blood loss during surgery. A prospective randomized controlled trial (RCT) was performed to investigate the best tourniquet strategy in TKA. The participants were randomly allocated to groups with different tourniquet strategies: Group 1) tourniquet inflation from skin to cement hardening (skin to cement); Group 2) tourniquet inflation only from cementation (cement only) and Group 3) tourniquet inflation from skin incision to skin closure (skin to skin). In addition to the blood loss and early postoperative outcomes, pain, soft tissue injury, and rehabilitation were also strictly monitored with a longer follow-up duration up to 6 months.
    Detailed Description
    A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the associated risks include skin burns, soft tissue and muscle damage, injury of calcified vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and thromboembolic events. The automatic lower limb pneumatic tourniquet system (Zimmer) was applied to reduce blood loss during surgery. The skin under the tourniquet was covered by cast padding. The operated leg was elevated and exsanguinated before inflating the automatic pneumatic tourniquet. There are three main strategies for the use of a tourniquet in TKR: A) inflate before incision and deflate following cement hardening ('skin to cement'); B) inflate prior to cement application and deflated following hardening ('cement only'); C) inflate before incision and deflate following completion of skin closure ('skin to skin'). The optimal timing of tourniquet application during primary TKA is still a matter of debate. Most previous reports have failed to show significant differences among different tourniquet strategies. Kvederas et al. compared these three strategies in a randomized double-blind clinical trial, and demonstrated that the estimated blood loss was highest when the tourniquet was inflated just before cement application and deflated after its hardening ('cement only'), while inflation of tourniquet before skin incision and its deflation after hardening of cement ('skin to cement') tends to give better early postoperative mobilization. However, this was an interim report with limited number of patients, and only limited outcome parameters were reported, which were insufficient to draw firm conclusions regarding the differences in outcome. Therefore we performed this prospective randomized controlled trial (RCT) with a decent sample size to investigate the best tourniquet strategy in TKA. In addition to the blood loss and early postoperative outcomes, we also strictly monitored pain, soft tissue injury, and rehabilitation with a longer follow-up duration up to 6 months. All of the operations were performed through the medial parapatellar approach by the same experienced joint replacement surgeon. All patients underwent primary TKA with minimally invasive techniques and cemented prostheses (EvolutionTM medial pivot, MicroPort, USA). An intramedullary guide was used for both tibial and femoral cuts. The automatic lower limb pneumatic tourniquet system was applied to reduce blood loss during surgery. The skin under the tourniquet was covered by cast padding. The operated leg was elevated and exsanguinated before inflating the automatic pneumatic tourniquet. One of the three tourniquet treatment strategies was used, as determined by the group allocation of the patient. In all the three groups, the tourniquet was inflated to a pressure of 280 mm Hg. The wound was closed after wound irrigation and hemostasis and then was wrapped with elastic bandages. One drainage was applied postoperatively in all patients and was kept until 24h to monitor blood loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee, Rheumatoid Arthritis of Knee
    Keywords
    Tourniquet, Total Knee Arthroplasty

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomization list was generated prior to recruitment using a computer software (Random Allocation Software Version 1.0.0, Isfahan, Iran). The participants were randomly allocated to either of the 3 groups with different tourniquet strategies: Group 1) tourniquet inflation from skin to cement hardening (skin to cement); Group 2) tourniquet inflation only from cementation (cement only); Group 3) tourniquet inflation from skin incision to skin closure (skin to skin). The surgeon opened a sealed envelope containing the allocation right before the operation in the theatre. The evaluators who examined and collected the data were blinded to the patients' allocation to the study groups.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cement only
    Arm Type
    Active Comparator
    Arm Description
    The tourniquet was inflated just before cement application and deflated after its hardening
    Arm Title
    Skin to Cement
    Arm Type
    Active Comparator
    Arm Description
    Inflation of tourniquet before skin incision and its deflation after hardening of cement
    Arm Title
    Skin to Skin
    Arm Type
    Active Comparator
    Arm Description
    Inflate of tourniquet before incision and deflate following completion of skin closure
    Intervention Type
    Procedure
    Intervention Name(s)
    Tourniquet
    Intervention Description
    A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation
    Primary Outcome Measure Information:
    Title
    Blood Loss
    Description
    We calculated the intraoperative blood loss by measuring the suction volume and weighing the sponges. Hemoglobin (Hb) and hematocrit (Hct) levels were examined preoperatively, and on Day 1 to Day 4 after surgery. Change of Hb and Hct was calculated as the value of postoperative D1 to D4 minus preoperative value. The number of patients undergoing blood transfusion were recorded. The criterion for a blood transfusion was set as a Hb level of <8 g/dL with symptomatic anemia. The calculated blood loss, which reflects actual blood loss, was determined with use of a previously described method. Briefly, the patients blood volume (PBV) is calculated using a formula, and multiplying the PBV by the change of haematocrit (preoperative value minus value on postoperative Day 2) will give the estimated total blood loss (ETBL).
    Time Frame
    4 days after surgery
    Secondary Outcome Measure Information:
    Title
    Soft-tissue damage
    Description
    We assessed soft-tissue damage by examining serum C-reactive protein (CRP), creatine kinase (CK), lactate dehydrogenase (LDH), and interleukin-6 (IL-6) levels preoperatively and on postoperative days 1, 2, 3 and 4
    Time Frame
    4 days after surgery
    Title
    Thigh circumference
    Description
    Thigh circumference was measured 10 cm proximal to the patella and leg circumference was measured 15 cm distal to the patella, to determine the degree of swelling, and was measured on postoperative days 1, 2, 3 and 4. X-rays were taken after surgery to measure the lower limb alignment, and tibial and femoral components position.
    Time Frame
    4 days after surgery
    Title
    Postoperative Visual Analog Scale
    Description
    Postoperative visual analog scale (VAS) scores were obtained for both knee and thigh pain preoperatively and on postoperative.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    Peak Quadriceps Strength
    Description
    The strength of each leg was evaluated by using an isokinetic dynamometer. Peak torque measured in both the concentric and eccentric modes.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    Time-up-and-go (TUG) Test
    Description
    he TUG test was used to evaluate the preoperative degree of mobility. This test involves measuring the time a patient needs to get up from a chair, walk three meters, turn, walk back to the chair and then sit down again.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    6-minute Walking Test
    Description
    A test that evaluates the functional capacity of the patient while walking on a flat, hard surface in the 6-minute window. It assess all the systems that are involved in the 6-minute window.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    Berg Balance Scale
    Description
    The BBS test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    Knee Society Knee Score
    Description
    A knee score that rates only the knee joint itself, there are three main parameters which are pain, stability and the range of motion. Whereas flexion contracture, extension lag and misalignment would be different ways for point deductions. 100 points would refer to a patient with no knee pain, 125 degree range of motion and negligible anteroposterior and mediolateral instability.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
    Title
    Knee Society Function Score
    Description
    A functional score that rates the patient's ability to walk and climb stairs, points would be deducted if the patient uses any walking aids for the two. 100 points would refer to a patient that can walk for an unlimited distance and go up and down the stairs without any trouble.
    Time Frame
    Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffer from primary osteoarthritis indicated for total knee arthroplasty Subject is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations Subject must have signed an informed consent document specific to the study, and approved by the Ethics Committee, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: Subject requires a revision knee arthroplasty surgery Subject is currently on anti-coagulant therapy or has coagulopathy Subject has peripheral vascular disease of the lower limb evidenced by the presence of blood vessel calcification on the radiographs or the absence of dorsalis pedis/popliteal pulses Subject suffers from conditions other than primary knee osteoarthritis, e.g. inflammatory arthritis Subject having associated medical diseases affecting rehabilitation Subject has active systemic infection or infection near the knee joint Subject having current medical condition that render them unfit for surgery Any criterion which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23318610
    Citation
    Tai TW, Chang CW, Lai KA, Lin CJ, Yang CY. Effects of tourniquet use on blood loss and soft-tissue damage in total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Dec 19;94(24):2209-15. doi: 10.2106/JBJS.K.00813.
    Results Reference
    background
    PubMed Identifier
    23836239
    Citation
    Tarwala R, Dorr LD, Gilbert PK, Wan Z, Long WT. Tourniquet use during cementation only during total knee arthroplasty: a randomized trial. Clin Orthop Relat Res. 2014 Jan;472(1):169-74. doi: 10.1007/s11999-013-3124-2.
    Results Reference
    background

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    A Study on the Use of Tourniquet Use In Primary Total Knee Arthroplasty

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