Clinical trial NCT04502459: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Rheumatoid Arthritis of Knee
Keywords: Tourniquet
Total Knee Arthroplasty
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Loss
timeFrame: 4 days after surgery
Secondary outcomes:
measure: Soft-tissue damage
timeFrame: 4 days after surgery
measure: Thigh circumference
timeFrame: 4 days after surgery
measure: Postoperative Visual Analog Scale
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: Peak Quadriceps Strength
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: Time-up-and-go (TUG) Test
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: 6-minute Walking Test
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: Berg Balance Scale
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: Knee Society Knee Score
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
measure: Knee Society Function Score
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6
Other outcomes:
Locations:
Study officials:
References:
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: 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.