RCT
ACE Report #10194

Similar efficacy of oral TXA to IA TXA in total knee arthroplasty without a tourniquet


Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A

Comparison of oral versus intra-articular tranexamic acid in enhanced-recovery primary total knee arthroplasty without tourniquet application: a randomized controlled trial

BMC Musculoskelet Disord. 2018 Mar 15;19(1):85

Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here

Synopsis

150 patients scheduled for total knee arthroplasty were randomized to either perioperative oral tranexamic acid or intraarticular tranexamic acid. Patients were assessed for perioperatively for total blood loss, intraoperative blood loss, the incidence of transfusion, number of transfused units, and postoperative complications. At 1-month and 3-month follow-up, patients were also assessed for knee circumference, health-related quality of life, mortality, and readmission. No significant differences were observed between groups in the perioerpative measures, including total blood loss, intraoperative blood loss, transfusion rate, and complication rate. Additionally, there were no significant differences between groups in outcomes at follow-up.

Publication Funding Details +
Funding:
Not Reported
Conflicts:
None disclosed

Risk of Bias

9/10

Reporting Criteria

20/21

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

4/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/5

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Tranexamic acid has been the subject of investigation for reducing blood loss in total knee arthroplasty. Early studies have focused on the intravenous and intra-articular application of tranexamic acid in these procedures. More recently, interest has grown in the application of oral tranexamic acid. While results from placebo-controlled trials have demonstrated efficacy, comparisons to other forms of tranexamic acid are needed.

What was the principal research question?

In total knee arthroplasty, is there a significant difference in total blood loss between oral tranexamic acid administration and intraarticular tranexamic acid administration?

Study Characteristics -
Population:
150 patients, 18 years of age or older, scheduled for primary, unilateral total knee arthroplasty due to primary osteoarthritis. All cases were completed under general anesthesia, through a medial parapatellar approach. Chemothroboprophylaxis was administered using low-molecular-weight heparin (Clexane; Sanofi-Aventis) and rivaroxaban.
Intervention:
Oral TXA group: Patients were administered four oral tranexamic acid 500mg tablets at approximately 2 hours prior to incision, and subsequent 1g doses at 6 and 12 hours postoperatively. (n=75; 74 analyzed) (Mean age: 65.0+/-13.1)
Comparison:
IA TXA group: Patients were administered a solution of 3g tranexamic acid in 100mL saline intraoperatively via intraarticular infiltration. (n=75; 73 analyzed) (Mean age: 63.6+/-11.5)
Outcomes:
The primary outcome was total blood loss, calculated using the Gross formula. Secondary outcomes included intraoperative blood loss, transfusion rate, number of units transfused, postoperative hemoglobin and hematocrit levels, the incidence of postoperative complications, quality of life on the QoR-40 measure, range of motion, pain, the Knee Society Score, knee circumference, 30-day mortality, and 90-day readmission.
Methods:
RCT; Patient- and assessor-blind
Time:
Patients were assessed perioperatively, and at 1 month and 3 months postoperatively.

What were the important findings?

  • Total blood loss did not significantly differ between the oral TXA group (788.8+/-349.1mL) and the IA TXA group (872.4+/-393.1mL) (p=0.21).
  • Intraoperative blood loss and transfusion rate did not significantly differ between the oral TXA group and the IA TXA group (p=0.58 and 0.73, respectively).
  • Hemoglobin and hematocrit level at 72 hours postoperatively did not significantly differ between the oral TXA group and the IA TXA group (p=0.22 and 0.20, respectively).
  • The incidence of complications did not significantly differ between the oral TXA group (2/74) and the IA TXA group (1/73). Complications included one case of DVT in the oral TXA group, one case of wound secretion in the oral TXA group, and one case of hematoma in the IA TXA group.
  • QoR-40, knee range of motion, and pain scores did not significantly differ between the oral TXA group and the IA TXA at 1 month or 3 months postoperatively.
  • No case of all cause 30-day mortality was observed in either group.
  • No case of all cause 90-day readmission was observed in either group.

What should I remember most?

In total knee arthroplasty, oral tranexamic acid and intraarticular tranexamic acid demonstrated no significant differences in total blood loss, transfusion rate, incidence of postoperative complications, or postoperative clinical and functional outcomes up to 3 months postoperatively.

How will this affect the care of my patients?

The results of this study suggest that oral tranexamic acid may offer similar effects to intraarticular tranexamic acid on blood loss, transfusion rate, postoperative outcomes, and complications following total knee arthroplasty.

CME Image

Continuing Medical Education Credits

You could be earning 0.5 CME credits for each report you read.

LEARN MORE

Please Login or Join to leave comments.

Robert Ghiz 2018-04-26 1:05 AM

Orthopaedic Surgeon - United States

A nice study.

Anonymous 2018-04-26 1:07 AM

Orthopaedic Surgeon - United States

A nice study.