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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.

Editor's Choice
  • Nuñez JH
  • Colomina J
  • Angles F
  • Pallisó F
  • Acosta HF
  • et al.
Arch Orthop Trauma Surg. 2024 Apr;144(4):1585-1595 doi: 10.1007/s00402-024-05243-3.
POPULATION:

Patients undergoing primary total hip or knee arthroplasty (5 studies, n= 17,667).

INTERVENTION:

Systematic review and meta-analysis to assess the necessity of routine pretransfusion tests before primary total hip or knee arthroplasty.

COMPARISON:

OUTCOME:

Pooled results revealed a 96.3% over-ordering pretransfusion test rate (95% CI [0.92, 1.00]) among patients undergoing primary total hip or knee arthroplasty. The pooled prevalence of hospital transfusion rate was 3.6%. There were statistically significant differences in preoperative haemoglobin (Hb) levels between patients not requiring transfusion (Hb= 13.9 g/dl; 95% CI [12.59, 15.20]) and those needing transfusion (Hb= 11.9 g/dl; 95% CI [10.69, 13.01]).

BACKGROUND:

The excessive routine ordering of pretransfusion tests (blood typing, screening, and cross-matching) for surgical cases incurs significant unnecessary costs and places an undue burden on transfusion services. This study aims to systematically review the literature regarding the necessity of routine pretransfusion tests before total hip arthroplasty (THA) or total knee arthroplasty (TKA) and summarize their outcomes.

STUDY METHODS:

A systematic review and meta-analysis were performed. The study's characteristics, the prevalence of over-ordering pretransfusion tests, transfusion rates, and potential cost savings to the healthcare system were analyzed.

RESULTS:

The study included 17,667 patients. Pooled results revealed a 96.3% over-ordering pretransfusion test rate (95% CI: 0.92-1.00; p < 0.001) among patients undergoing primary THA or TKA. The pooled prevalence of hospital transfusion rate was 3.6%. Notably, there were statistically significant differences in preoperative hemoglobin (Hb) levels between patients not requiring transfusion (Hb = 13.9 g/dl; 95% CI 12.59-15.20; p < 0.001) and those needing transfusion (Hb = 11.9 g/dl; 95% CI 10.69-13.01; p < 0.001) (p = 0.03). The per-patient total cost savings ranged from 28.63 to 191.27 dollars.

DISCUSSION:

Our study suggests that routine pre-transfusion testing for all patients undergoing primary THA or TKA may be unnecessary. We propose limiting pretransfusion test orders to patients with preoperative hemoglobin levels below 12 g/dl in unilateral primary TKA or THA. This targeted approach can result in significant cost savings for healthcare systems and transfusion services by reducing the over-ordering of pretransfusion tests in these surgical procedures.

Editor's Choice
  • Moulton SG
  • Hartwell MJ
  • Feeley BT
Am J Sports Med. 2024 Feb 7;3635465231213039 doi: 10.1177/03635465231213039.
POPULATION:

Patients undergoing arthroscopic rotator cuff repair surgery with platelet-rich plasma (PRP) (25 studies).

INTERVENTION:

Systematic review to evaluate the presence of spin bias in the abstracts of systematic reviews and meta-analyses of PRP with rotator cuff repair surgery.

COMPARISON:

OUTCOME:

Each included study was evaluated for the 15 most common forms of spin. Correlations between spin types and study characteristics were evaluated. At least 1 form of spin bias was found in 56% (14/25) of the included studies. In regard to the 3 different categories of spin, a form of misleading interpretation was found in 56% (14/25) of the studies. A form of misleading reporting was found in 48% (12/25) of the studies. A form of inappropriate extrapolation was found in 16% (4/25) of the studies. A significant association was found between misleading interpretation and publication year (odds ratio (OR) 1.41 per year increase in publication; 95% CI [1.04, 1.92]) and misleading reporting and publication year (OR 1.41 per year increase in publication; 95% CI [1.02, 1.95]). An association was found between inappropriate extrapolation and journal impact factor (OR 0.21 per unit increase in impact factor; 95% CI [0.044, 0.99]).

BACKGROUND:

The use of platelet-rich plasma (PRP) in orthopaedics continues to increase. One common use of PRP is as an adjunct in rotator cuff repair surgery. Multiple systematic reviews and meta-analyses have summarized the data on PRP use in rotator cuff repair surgery. However, systematic reviews and meta-analyses are subject to spin bias, where authors' interpretations of results influence readers' interpretations.

PURPOSE:

To evaluate spin in the abstracts of systematic reviews and meta-analyses of PRP with rotator cuff repair surgery.

STUDY DESIGN:

Systematic review; Level of evidence, 3.

METHODS:

A PubMed and Embase search was conducted using the terms rotator cuff repair and PRP and systematic review or meta-analysis. After review of 74 initial studies, 25 studies met the inclusion criteria. Study characteristics were documented, and each study was evaluated for the 15 most common forms of spin and using the AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, Version 2) rating system. Correlations between spin types and study characteristics were evaluated using binary logistic regression for continuous independent variables and a chi-square test or Fisher exact test for categorical variables.

RESULTS:

At least 1 form of spin was found in 56% (14/25) of the included studies. In regard to the 3 different categories of spin, a form of misleading interpretation was found in 56% (14/25) of the studies. A form of misleading reporting was found in 48% (12/25) of the studies. A form of inappropriate extrapolation was found in 16% (4/25) of the studies. A significant association was found between misleading interpretation and publication year (odds ratio [OR], 1.41 per year increase in publication; 95% CI, 1.04-1.92; P = .029) and misleading reporting and publication year (OR, 1.41 per year increase in publication; 95% CI, 1.02-1.95; P = .037). An association was found between inappropriate extrapolation and journal impact factor (OR, 0.21 per unit increase in impact factor; 95% CI, 0.044-0.99; P = .048).

CONCLUSION:

A significant amount of spin was found in the abstracts of systematic reviews and meta-analyses of PRP use in rotator cuff repair surgery. Given the increasing use of PRP by clinicians and interest among patients, spin found in these studies may have a significant effect on clinical practice.