Tourniquet
ProcedureA tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation
NCT Number: NCT04502459
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation
Time frame: 4 days after surgery
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
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
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: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
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
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
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
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
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
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
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.
The University of Hong Kong
Other
A Prospective Randomized Trial on the Use of Tourniquet in Primary Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07258693
Osteo Arthritis Knee
Las Palmas de Gran Canaria, Spain
View Trial DetailsNCT06257537
Arthritis, Joint Diseases
Stamford, Connecticut, United States
View Trial DetailsNCT06965946
Arthritis, Joint Diseases
Peshawar, Khyber Pakhtunkhwa, Pakistan
View Trial DetailsNCT06084988
Osteo Arthritis Knee
Abu Dhabi, United Arab Emirates
View Trial Details