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

NCT04502459 | Completed

• 1 other identifier: UW 15-129
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteo Arthritis Knee; Rheumatoid Arthritis of Knee

Keywords

Tourniquet; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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).

  4 days after surgery

Secondary Outcomes (9)

• Soft-tissue damage

  4 days after surgery

• Thigh circumference

  4 days after surgery

• Postoperative Visual Analog Scale

  Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6

• Peak Quadriceps Strength

  Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6

• Time-up-and-go (TUG) Test

  Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6

Study Arms (3)

Cement only

ACTIVE COMPARATOR

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

Procedure: Tourniquet

Skin to Cement

ACTIVE COMPARATOR

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

Procedure: Tourniquet

Skin to Skin

ACTIVE COMPARATOR

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

Procedure: Tourniquet

Interventions

Tourniquet PROCEDURE

A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation

Cement only; Skin to Cement; Skin to Skin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 6, 2020
• Study Start: May 5, 2015
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: August 6, 2020

Record last verified: 2020-08