<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502459</url>
  </required_header>
  <id_info>
    <org_study_id>UW 15-129</org_study_id>
    <nct_id>NCT04502459</nct_id>
  </id_info>
  <brief_title>A Study on the Use of Tourniquet Use In Primary Total Knee Arthroplasty</brief_title>
  <official_title>A Prospective Randomized Trial on the Use of Tourniquet in Primary Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization,&#xD;
      reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the&#xD;
      associated risks include skin burns, soft tissue and muscle damage, injury of calcified&#xD;
      vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and&#xD;
      thromboembolic events. The automatic lower limb pneumatic tourniquet system (Zimmer) was&#xD;
      applied to reduce blood loss during surgery. A prospective randomized controlled trial (RCT)&#xD;
      was performed to investigate the best tourniquet strategy in TKA. The participants were&#xD;
      randomly allocated to groups with different tourniquet strategies: Group 1) tourniquet&#xD;
      inflation from skin to cement hardening (skin to cement); Group 2) tourniquet inflation only&#xD;
      from cementation (cement only) and Group 3) tourniquet inflation from skin incision to skin&#xD;
      closure (skin to skin). In addition to the blood loss and early postoperative outcomes, pain,&#xD;
      soft tissue injury, and rehabilitation were also strictly monitored with a longer follow-up&#xD;
      duration up to 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization,&#xD;
      reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the&#xD;
      associated risks include skin burns, soft tissue and muscle damage, injury of calcified&#xD;
      vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and&#xD;
      thromboembolic events.&#xD;
&#xD;
      The automatic lower limb pneumatic tourniquet system (Zimmer) was applied to reduce blood&#xD;
      loss during surgery. The skin under the tourniquet was covered by cast padding. The operated&#xD;
      leg was elevated and exsanguinated before inﬂating the automatic pneumatic tourniquet. There&#xD;
      are three main strategies for the use of a tourniquet in TKR: A) inflate before incision and&#xD;
      deflate following cement hardening ('skin to cement'); B) inflate prior to cement application&#xD;
      and deflated following hardening ('cement only'); C) inflate before incision and deflate&#xD;
      following completion of skin closure ('skin to skin'). The optimal timing of tourniquet&#xD;
      application during primary TKA is still a matter of debate. Most previous reports have failed&#xD;
      to show signiﬁcant differences among different tourniquet strategies.&#xD;
&#xD;
      Kvederas et al. compared these three strategies in a randomized double-blind clinical trial,&#xD;
      and demonstrated that the estimated blood loss was highest when the tourniquet was inﬂated&#xD;
      just before cement application and deﬂated after its hardening ('cement only'), while&#xD;
      inﬂation of tourniquet before skin incision and its deﬂation after hardening of cement ('skin&#xD;
      to cement') tends to give better early postoperative mobilization. However, this was an&#xD;
      interim report with limited number of patients, and only limited outcome parameters were&#xD;
      reported, which were insufﬁcient to draw ﬁrm conclusions regarding the differences in&#xD;
      outcome.&#xD;
&#xD;
      Therefore we performed this prospective randomized controlled trial (RCT) with a decent&#xD;
      sample size to investigate the best tourniquet strategy in TKA. In addition to the blood loss&#xD;
      and early postoperative outcomes, we also strictly monitored pain, soft tissue injury, and&#xD;
      rehabilitation with a longer follow-up duration up to 6 months.&#xD;
&#xD;
      All of the operations were performed through the medial parapatellar approach by the same&#xD;
      experienced joint replacement surgeon. All patients underwent primary TKA with minimally&#xD;
      invasive techniques and cemented prostheses (EvolutionTM medial pivot, MicroPort, USA). An&#xD;
      intramedullary guide was used for both tibial and femoral cuts.&#xD;
&#xD;
      The automatic lower limb pneumatic tourniquet system was applied to reduce blood loss during&#xD;
      surgery. The skin under the tourniquet was covered by cast padding. The operated leg was&#xD;
      elevated and exsanguinated before inﬂating the automatic pneumatic tourniquet. One of the&#xD;
      three tourniquet treatment strategies was used, as determined by the group allocation of the&#xD;
      patient. In all the three groups, the tourniquet was inﬂated to a pressure of 280 mm Hg. The&#xD;
      wound was closed after wound irrigation and hemostasis and then was wrapped with elastic&#xD;
      bandages. One drainage was applied postoperatively in all patients and was kept until 24h to&#xD;
      monitor blood loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2015</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Loss</measure>
    <time_frame>4 days after surgery</time_frame>
    <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 &lt;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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Soft-tissue damage</measure>
    <time_frame>4 days after surgery</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh circumference</measure>
    <time_frame>4 days after surgery</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Visual Analog Scale</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <description>Postoperative visual analog scale (VAS) scores were obtained for both knee and thigh pain preoperatively and on postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Quadriceps Strength</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <description>The strength of each leg was evaluated by using an isokinetic dynamometer. Peak torque measured in both the concentric and eccentric modes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-up-and-go (TUG) Test</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walking Test</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <description>The BBS test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Knee Score</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Function Score</measure>
    <time_frame>Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <condition>Rheumatoid Arthritis of Knee</condition>
  <arm_group>
    <arm_group_label>Cement only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The tourniquet was inﬂated just before cement application and deﬂated after its hardening</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skin to Cement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inﬂation of tourniquet before skin incision and its deﬂation after hardening of cement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skin to Skin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inflate of tourniquet before incision and deflate following completion of skin closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tourniquet</intervention_name>
    <description>A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation</description>
    <arm_group_label>Cement only</arm_group_label>
    <arm_group_label>Skin to Cement</arm_group_label>
    <arm_group_label>Skin to Skin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients suffer from primary osteoarthritis indicated for total knee arthroplasty&#xD;
&#xD;
          2. Subject is physically and mentally willing and able to comply with the postoperative&#xD;
             scheduled clinical and radiographic evaluations&#xD;
&#xD;
          3. Subject must have signed an informed consent document specific to the study, and&#xD;
             approved by the Ethics Committee, indicating that they understand the purpose of and&#xD;
             procedures required for the study and are willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject requires a revision knee arthroplasty surgery&#xD;
&#xD;
          2. Subject is currently on anti-coagulant therapy or has coagulopathy&#xD;
&#xD;
          3. Subject has peripheral vascular disease of the lower limb evidenced by the presence of&#xD;
             blood vessel calcification on the radiographs or the absence of dorsalis&#xD;
             pedis/popliteal pulses&#xD;
&#xD;
          4. Subject suffers from conditions other than primary knee osteoarthritis, e.g.&#xD;
             inflammatory arthritis&#xD;
&#xD;
          5. Subject having associated medical diseases affecting rehabilitation&#xD;
&#xD;
          6. Subject has active systemic infection or infection near the knee joint&#xD;
&#xD;
          7. Subject having current medical condition that render them unfit for surgery&#xD;
&#xD;
          8. Any criterion which in the opinion of the investigator, suggests that the subject&#xD;
             would not be compliant with the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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.</citation>
    <PMID>23318610</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23836239</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Yan Chun-Hoi</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Tourniquet</keyword>
  <keyword>Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502459
org study id: UW 15-129
nct id: NCT04502459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Blood Loss
time frame: 4 days after surgery
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).
measure: Soft-tissue damage
time frame: 4 days after surgery
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
measure: Thigh circumference
time frame: 4 days after surgery
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.
measure: Postoperative Visual Analog Scale
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
description: Postoperative visual analog scale (VAS) scores were obtained for both knee and thigh pain preoperatively and on postoperative.
measure: Peak Quadriceps Strength
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
description: The strength of each leg was evaluated by using an isokinetic dynamometer. Peak torque measured in both the concentric and eccentric modes.
measure: Time-up-and-go (TUG) Test
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
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.
measure: 6-minute Walking Test
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
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.
measure: Berg Balance Scale
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
description: The BBS test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
measure: Knee Society Knee Score
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
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.
measure: Knee Society Function Score
time frame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
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.
arm group label: Cement only
arm group type: Active Comparator
description: The tourniquet was inﬂated just before cement application and deﬂated after its hardening
arm group label: Skin to Cement
arm group type: Active Comparator
description: Inﬂation of tourniquet before skin incision and its deﬂation after hardening of cement
arm group label: Skin to Skin
arm group type: Active Comparator
description: Inflate of tourniquet before incision and deflate following completion of skin closure
intervention type: Procedure
intervention name: Tourniquet
description: A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation
arm group label: Cement only
arm group label: Skin to Cement
arm group label: Skin to Skin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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.
PMID: 23318610
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.
PMID: 23836239
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Yan Chun-Hoi
investigator title: Clinical Associate Professor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided