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Editor's Choice
  • Brown AN
  • Yendluri A
  • Lawrence KW
  • Cordero JK
  • Moucha CS
  • et al.
J Am Acad Orthop Surg. 2024 Jun 1;32(11):508-515 doi: 10.5435/JAAOS-D-23-00503.
POPULATION:

Patients undergoing orthopaedic surgery (108 randomised controlled trials).

INTERVENTION:

Tranexamic acid (TXA).

COMPARISON:

Placebo/control; other antifibrinolytic/clotting agents; TXA with a different dose or route of administration.

OUTCOME:

A total of 192 outcomes were reported across the 108 included studies. The median fragility index (FI) of the 192 outcomes was 4 (IQR= 2, 5) with an associated fragility quotient (FQ) of 0.03 (IQR= 0.019, 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR= 1, 5) and associated FQ of 0.02 (IQR= 0.011, 0.034). 147 outcomes were reported as nonsignificant with a median reverse fragility index of 4 (IQR= 3, 5) and associated FQ of 0.04 (IQR= 0.023, 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6.

INTRODUCTION:

Randomized controlled trials (RCTs) represent the highest level of evidence in orthopaedic surgery literature, although the robustness of statistical findings in these trials may be unreliable. We used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes reported in RCTs that assess the use of tranexamic acid (TXA) across orthopaedic subspecialties.

METHODS:

PubMed, EMBASE, and MEDLINE were queried for RCTs (2010-present) reporting dichotomous outcomes with study groups stratified by TXA administration. The FI and rFI were defined as the number of outcome event reversals needed to alter the significance level of significant and nonsignificant outcomes, respectively. FQ was determined by dividing the FI or rFI by sample size. Subgroup analyses were conducted based on orthopaedic subspecialty.

RESULTS:

Six hundred five RCTs were screened with 108 studies included for analysis comprising 192 total outcomes. The median FI of the 192 outcomes was 4 (IQR 2 to 5) with an associated FQ of 0.03 (IQR 0.019 to 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR 1 to 5) and associated FQ of 0.02 (IQR 0.011 to 0.034). 147 outcomes were reported as nonsignificant with a median rFI of 4 (IQR 3 to 5) and associated FQ of 0.04 (IQR 0.023 to 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6.

DISCUSSION:

Statistical outcomes reported in RCTs on the use of TXA in orthopaedic surgery are fragile. Reversal of a few outcomes is sufficient to alter statistical significance. We recommend reporting FI, rFI, and FQ metrics to aid in interpreting the outcomes reported in comparative trials.

Editor's Choice
  • Elmenawi KA
  • Mohamed FAE
  • Poilvache H
  • Prokop LJ
  • Abdel MP
  • et al.
J Arthroplasty. 2024 Apr 16; doi: 10.1016/j.arth.2024.04.033.
POPULATION:

Patients undergoing total hip and knee arthroplasty (6 studies n= >2million).

INTERVENTION:

Tranexamic acid (TXA).

COMPARISON:

No TXA.

OUTCOME:

Among 2,098,469 arthroplasties, TXA utilization was associated with an overall lower risk of periprosthetic joint infection (PJI) (OR 0.63; 95% CI [0.42, 0.96]) and a 0.4% lower incidence of PJI (RD -0.0038; 95% CI [-0.005, -0.002]). When sub-grouping the studies according to length of follow-up, TXA was associated with a lower risk of PJI (OR 0.43; 95% CI [0.35, 0.53]) and a 1% lower incidence of PJI (RD -0.0095; 95% CI [-0.013, -0.005]) in patients followed for more than 90 days.

BACKGROUND:

The purpose of this study was to perform a systematic review and meta-analysis to evaluate the association between tranexamic acid (TXA) use during primary total hip arthroplasty (THA) and primary total knee arthroplasty (TKA), and the risk of developing periprosthetic joint infection (PJI) after these procedures.

METHODS:

A systematic review was carried out from inception to October 17, 2022. There were 6 studies that were ultimately included in the meta-analysis. The association between the development of PJI and TXA was analyzed using odds ratios (ORs) with 95% confidence intervals (CIs) and estimates of risk difference (RD). Subgroup analysis was performed to evaluate only studies reporting out to 90 days of follow-up versus more than 90 days of follow-up.

RESULTS:

Among 2,098,469 arthroplasties, TXA utilization was associated with an overall lower risk of PJI (OR = 0.63 [95% CI 0.42 to 0.96], P < .001) and a 0.4% lower incidence of PJI (RD = -0.0038, 95% CI [-0.005 to -0.002], P < .001). When subgrouping the studies according to length of follow-up, TXA was associated with a lower risk of PJI (OR = 0.43 [95% CI 0.35 to 0.53], P < .001) and a 1% lower incidence of PJI (RD = -0.0095 [95% CI -0.013 to -0.005], P < .001) in patients followed for more than 90 days.

CONCLUSIONS:

This meta-analysis demonstrates that TXA use is associated with a reduced risk of PJI, with our RD analysis identifying an approximately 0.4% reduction in PJI rates with TXA use. These findings provide even more data to support the routine use of TXA during primary THA and primary TKA.