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
About this trial
This is an interventional supportive care trial for Osteo Arthritis Knee focused on measuring Tourniquet, Total Knee Arthroplasty
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
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
NCT ID
NCT04502459
First Posted
July 14, 2020
Last Updated
August 4, 2020
Sponsor
The University of Hong Kong
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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