Abstract
Background
Tranexamic acid (TXA) is increasingly used to minimize blood loss associated with total hip replacement (THR), yet its comparative efficacy in inflammatory versus degenerative arthritis during THR remains underexplored in Indian patients. The objective of this study was to evaluate and compare the estimated intraoperative blood loss in patients undergoing THR with and without TXA administration, stratified by underlying degenerative and inflammatory joint conditions.
Methods
This retrospective cohort study analyzed medical records of patients undergoing THR at a single center from October 2020 to October 2023. Patients were stratified by TXA usage and the type of arthritis (inflammatory and degenerative). The primary outcome was intraoperative blood loss, while secondary outcomes included operative time and time to full weight-bearing.
Results
The study enrolled 126 patients, including 21 with inflammatory arthritis and 105 with degenerative arthritis, of whom 106 received TXA (n = 19, inflammatory arthritis; n = 87, degenerative arthritis).
The primary outcome of mean intraoperative blood loss was lower in the TXA group (350.57 ± 162.36 mL) compared to the non-TXA group (380.00 ± 192.22 mL), although this difference did not reach statistical significance (p = 0.472).
Secondary outcome, operative time was significantly shorter in patients receiving TXA (88.53 ± 24.38 min) compared to those who did not receive TXA (102.58 ± 45.27 min, p = 0.046). While the time to full weight-bearing was comparable between the TXA users and non-users (p = 0.341).
Subgroup analysis suggested a more pronounced reduction in blood loss with TXA use among patients with degenerative arthritis than those with inflammatory arthritis, though the difference was not statistically significant.
Conclusion
TXA administration in THR significantly reduced operative time but showed no significant difference in blood loss or postoperative recovery. The results suggest a potential for more pronounced benefits in patients with degenerative arthritis.
Keywords: Antifibrinolytic agent, Arthroplasty hip, Arthritis, Hemorrhage, Postoperative complications
1. Introduction
Total hip replacement (THR) is one of the most successful surgical interventions, consistently helping as the treatment of choice for achieving long-term functional restoration in patients with a variety of hip conditions.1 This procedure is particularly indicated for severe hip arthritis, which includes degenerative conditions such as osteoarthritis and avascular necrosis, as well as inflammatory disorders like rheumatoid arthritis and ankylosing spondylitis.1 Due to its proven efficacy in alleviating pain and improving mobility, THR also significantly improves the quality of life for affected individuals. However, significant perioperative blood loss remains a concern, potentially leading to increased morbidity, prolonged hospitalization, and the necessity for blood transfusions.2 Surgical trauma initiates the activation of the fibrinolytic system by stimulating tissue plasminogen activator (t-PA), which subsequently results in an increase in fibrinolysis and contributes to elevated blood loss during and after the procedure.3 This remains a prominent challenge in both inflammatory as well as degenerative conditions. Blood loss during THR can range from 1188 to 1651 mL, with Indian studies reporting averages between 965.30 (±523.02) to 1105.57 (±643.35) mL.4,5
Several strategies have been implemented to reduce intraoperative blood loss, including the use of hypotensive anesthesia and allogeneic blood products. However, each of these approaches carries inherent risks. Hypotensive anesthesia poses potential hemodynamic risks, and the use of allogeneic blood products raises concerns regarding infections and the potential for altered immune responses.6 To mitigate these risks, antifibrinolytic agents such as tranexamic acid (TXA) have been employed as an alternative strategy to reduce blood loss during orthopedic procedures. TXA is a synthetic lysine analog that inhibits plasminogen activation, thereby preventing fibrin degradation and stabilizing blood micro clots. It is widely used in orthopedic surgeries for reducing blood loss and transfusion requirements in total joint arthroplasty with well-documented efficacy, safety, and cost-effectiveness.7
While the general efficacy of TXA in reducing blood loss during THR is established, its comparative effectiveness in patients with inflammatory and degenerative hip arthritis remains unclear, given their distinct pathophysiological mechanisms.
Inflammatory arthritis is characterized by systemic inflammation, synovial hyperplasia, and increased vascularity, which may contribute to greater intraoperative blood loss and altered coagulation profiles.8, 9, 10 In contrast, degenerative arthritis primarily involves cartilage degradation with minimal systemic inflammation, potentially allowing for more predictable hemostatic responses.11,12 These differences could influence the efficacy of TXA in minimizing blood loss during THR. However, limited evidence is available comparing TXA's effectiveness in these two populations, particularly in the Indian context.
The primary objective of our study is to evaluate and compare the estimated intraoperative blood loss in patients undergoing THR with and without TXA in patients with degenerative versus inflammatory conditions. Secondary objectives include documenting and analyzing complications or the need for re-surgery in the postoperative period and evaluating the average operative time in patients with and without TXA administration.
2. Methods
2.1. Study design and ethical considerations
This observational, retrospective, cohort, single-center study was conducted at our institute over a period of three years. Medical records of patients undergoing THR between October 2020 and October 2023 were reviewed. The study was approved by the Institutional Ethics Committee (Approval No. 2024-171 dated December 20, 2024). Patients were informed about the study objectives, procedures, potential risks, and benefits. Written informed consent was obtained from all participants before their inclusion in the study. Patient confidentiality was maintained by anonymizing records and using unique identifiers. Data were securely stored in a password-protected database accessible only to authorized personnel.
2.2. Participants
Patients aged 18 years or older who underwent THR for either degenerative or inflammatory arthritis during the specified period were included. All patients underwent uncemented THR with implants from the same company. Although the surgeries were performed by different surgeons, as surgeries were performed in a single center, they were performed as per the standardized surgical protocol for THR in our institute, including preoperative planning, surgical approach, implant type, and postoperative management. Also, any deviations from the protocol were documented.
Patients in the TXA group had undergone pre-anesthetic evaluation and were found to be fit or with no contraindications for tranexamic acid administration. Patients in the TXA group received a single intravenous bolus dose of 1g TXA administered 20 min prior to surgical incision. No multiple doses or topical applications of TXA were used in the study population. This dosing regimen was consistent across all patients receiving TXA.
Key inclusion criteria included complete medical records documenting intraoperative blood loss, operative time, antifibrinolytic use, and postoperative outcomes. Patients were excluded if they had incomplete records, underwent surgeries other than THR, had conditions unrelated to arthritis, or exhibited abnormal coagulation parameters such as deranged bleeding time/coagulation time or prothrombin time/international normalized ratio values.
2.3. Sample size calculation
The sample size was estimated using a pooled standard deviation of 465.5 mL and a mean difference of 640 mL between TXA and non-TXA groups based on prior studies. This calculation yielded a requirement of 18 patients per group, ensuring 80 % power and a 5 % significance level.
2.4. Data collection and outcome measures
Data were collected retrospectively from medical records, encompassing demographics (age, sex), clinical characteristics (type of arthritis, comorbidities), surgical parameters (blood loss, operative time, drain output), and postoperative outcomes (time to full weight-bearing). Patients were stratified based on the use of TXA, such as those who received TXA 1g, IV STAT, and those who did not. The patients were also categorized by the type of arthritis as inflammatory or degenerative arthritis.
2.5. Statistical analysis
Descriptive statistics summarized demographic and clinical data. Comparative analyses were performed using t-tests, chi-square tests, or ANOVA to assess differences in blood loss and functional outcomes. Subgroup analyses stratified results by arthritis type and TXA usage.
Missing data were addressed using sensitivity analyses and mean imputation methods, where missing values were replaced with the average of non-missing values for the respective variable. This method assumes that missing data are missing at random and helps to minimize data loss while maintaining the overall distribution of the dataset. Sensitivity analyses were performed to evaluate the impact of imputed data on the primary and secondary outcomes, showing consistent findings.
3. Results
3.1. Demographic and clinical characteristics
Table 1 presents the demographic and clinical characteristics of the study cohort, stratified by TXA usage. Among the 126 patients included, TXA was used in 106 patients, while it was not used in 20 patients. Furthermore, 21 (19 TXA users, 2 TXA on-users) of the 126 included patients had inflammatory arthritis, and 105 had degenerative arthritis (87 TXA users, 18 TXA on-users). The mean age of patients receiving TXA was 43.51 years, compared to 40.30 years for those who did not receive TXA. Gender distribution was comparable across groups, with a higher proportion of male patients in both TXA (65.1 %) and non-TXA groups (65.0 %). The majority of patients underwent surgery under spinal + epidural anesthesia. TXA use did not significantly affect re-surgery rates.
Table 1.
Demographic and clinical characteristics as per TXA use.
| Variable | TXA used (n = 106) | TXA not used (n = 20) | p-value |
|---|---|---|---|
| Mean age (years) | 43.51 ± 13.97 | 40.30 ± 14.24 | 0.349 |
| Male % (n) | 65.1 (37) | 65.0 (7) | 0.994 |
| Arthritis type | |||
| Inflammatory arthritis % (n) | 17.92 (19) | 10 (2) | – |
| Degenerative arthritis % (n) | 82.07 (87) | 90 (18) | – |
| Anesthesia | |||
| General % (n) | 1.9 (2) | 0.0 (0) | 0.552 |
| Spinal % (n) | 3.8 (4) | 0.0 (0) | |
| Spinal + Epidural % (n) | 94.3 (100) | 100.0 (20) | |
| Re-surgery Required % (n) | 7.5 (8) | 0.0 (0) | 0.204 |
TXA: Tranexamic acid. ∗p-value of ≤0.05 was considered statistically significant.
3.2. Comparative analysis of clinical outcomes as per tranexamic acid usage
Table 2 outlines the comparative analysis of clinical outcomes based on TXA usage. TXA use was associated with significantly lower operative time (p = 0.046). However, there were no significant differences in intraoperative blood loss or time to full weight-bearing between TXA and non-TXA groups. Drain output was lower in the TXA group but was not statistically significant (p = 0.052).
Table 2.
Clinical outcomes with and without TXA.
| Parameter | TXA Used (n = 106) | TXA Not Used (n = 20) | t-value | p-value |
|---|---|---|---|---|
| Blood Loss (mL) | 350.57 ± 162.36 | 380.00 ± 192.22 | −0.722 | 0.472 |
| Drain Output (mL) | 118.89 ± 108.38 | 183.33 ± 77.85 | −1.972 | 0.052 |
| Operative time (minutes) | 88.53 ± 24.38 | 102.58 ± 45.27 | −2.016 | 0.046∗ |
| Time to Full Weight-Bearing (days) | 34.06 ± 7.44 | 35.80 ± 7.76 | −0.955 | 0.341 |
∗p-value of ≤0.05 was considered statistically significant.
3.3. Subgroup analysis by TXA use
Table 3 shows the subgroup analysis of outcomes based on TXA use within inflammatory and degenerative arthritis groups. Among patients with degenerative arthritis, TXA use was associated with a reduction in blood loss, although statistical significance was not achieved (p = 0.208). However, in the inflammatory arthritis subgroup, although not statistically significant, TXA use was associated with higher blood loss, likely due to the small sample size of non-TXA patients. Subgroup analysis showed that operative times were lower in TXA users than non-users in both inflammatory and degenerative arthritis subgroups; however, statistical significance was not reached (p = 0.093 and 0.116, respectively). Time to full weight-bearing was not significantly affected by TXA use in either arthritis subgroup.
Table 3.
Subgroup analysis by TXA and arthritis type.
| Parameter | Inflammatory with TXA (n = 19) | Inflammatory with no TXA (n = 2) | t-value | p-value | Degenerative with TXA (n = 87) | Degenerative with No TXA (n = 18) | t-value | p-value |
|---|---|---|---|---|---|---|---|---|
| Blood Loss (mL) | 428.95 ± 142.71 | 300.00 ± 0.00 | 1.249 | 0.227 | 333.45 ± 162.07 | 388.89 ± 201.14 | −1.266 | 0.208 |
| Drain Output (mL) | 113.53 ± 60.41 | – | – | – | 120.55 ± 119.79 | 183.33 ± 77.85 | −1.732 | 0.088 |
| Operative time (minutes) | 88.59 ± 24.53 | 120.00 ± 0.00 | −1.769 | 0.093 | 88.51 ± 24.49 | 100.64 ± 47.44 | −1.586 | 0.116 |
| Time to Full Weight-Bearing (days) | 35.68 ± 6.18 | 30.00 ± 0.00 | 1.271 | 0.219 | 33.70 ± 7.67 | 36.44 ± 7.93 | −1.373 | 0.173 |
∗p-value of ≤0.05 was considered statistically significant.
3.4. Complications
A total of 13 incidents of complications were reported in our study cohort. These included 2 cases of dislocation, 3 cases of deep infection, 1 case of superficial infection, 2 cases of aseptic loosening on the femoral side, and 1 case on the acetabular side. Iatrogenic fractures were observed in 4 patients. Notably, no cases of osteolysis or periprosthetic fractures were recorded in the study population. Also, no TXA-related thrombotic events were reported in the study population.
4. Discussion
This retrospective cohort study evaluated the efficacy of TXA in reducing blood loss during THR among patients with inflammatory and degenerative hip arthritis. Our findings indicate that TXA administration is associated with a significant reduction in operative time. This has important clinical implications, as shorter operative times can improve surgical workflow efficiency, reduce anesthesia duration, and potentially decrease the risk of perioperative complications. The impact of TXA use on intraoperative blood loss and postoperative recovery, as measured by time to full weight-bearing, was not statistically significant in both arthritis subgroups. However, the numerically greater effect suggests that TXA may offer clinically relevant benefits. The subgroup analysis showed a more pronounced effect of TXA in the degenerative hip arthritis cohort in terms of reduction in blood loss.
In recent years, TXA, being an antifibrinolytic agent, has played a significant role in reducing the need for blood transfusions in THAR and total knee arthroplasty (TKA). Literature supports the safety and efficacy of TXA in both primary and revision THA and TKA, demonstrating its effectiveness in minimizing blood loss, reducing the requirement for allogeneic transfusions, and decreasing perioperative complications. Additionally, the use of TXA has been associated with shorter hospital stays, reduced healthcare costs, and lower readmission rates.13 Studies have demonstrated that TXA administration leads to significant reductions in total blood loss and transfusion requirements in patients undergoing THA. A meta-analysis reported that both intravenous and topical applications of TXA significantly decreased blood loss and the need for transfusions in THA patients without increasing the risk of thromboembolic events.14 A randomized controlled trial also showed that multiple doses of intravenous TXA also reduce hidden blood loss after THA.15 Fraval et al. demonstrated a significant reduction in perioperative blood loss with TXA across various orthopedic procedures, also with a positive effect on reducing the duration of inpatient stays.16 Another systematic review and meta-analysis showed that TXA reduces surgical blood loss by approximately one-third across various procedures, including orthopedic surgeries.17 In our study, the mean intraoperative blood loss was also lower in the TXA group compared to the non-TXA group, though this difference did not reach statistical significance. The small sample size may have limited statistical power. In subgroup analysis, although not significant, a higher reduction in blood loss was observed with TXA use in the degenerative arthritis cohort. In contrast, TXA use was associated with non-significant but higher mean blood loss than non-use in the inflammatory arthritis subgroup. Studies have reported that patients with inflammatory arthritis often present with complex joint deformities, leading to prolonged operative times and increased surgical challenges, which may influence intraoperative blood loss.18 This highlights the need for tailored surgical strategies in this subgroup. Persistent wound drainage is a recognized complication associated with THA, often raising concerns about the risk of infection and delayed recovery.19 The use of surgical drainage following THA and TKA remains a longstanding practice aimed at managing postoperative wound exudate and minimizing complications.20 The clinical implications of reduced drain output include a potential decrease in hematoma formation, diminished swelling, and a lower risk of infection, all of which can contribute to improved patient outcomes.21 Clinical evidence suggests that TXA use is also associated with reduced drain output in patients undergoing THR. Randomized and retrospective cohort studies have reported that TXA use effectively reduces total drainage output in THR surgeries.22,23 Meta-analysis by Gianakos et al.24 and Yoon et al.25 also concluded that TXA effectively reduces drain output along with total blood loss in total hip arthroplasty.24 Our findings also suggested a trend toward reduced drain output with TXA use. Although this difference was not statistically significant, the observed effect may have clinical relevance in minimizing postoperative complications such as hematoma formation, swelling, and infection risk, further enhancing recovery.
Prolonged operative time in THA may lead to increased bleeding from bony and soft-tissue surfaces, affecting the efficiency of surgical procedures. The existing literature primarily focuses on blood loss and transfusion requirements as a measure of TXA efficacy, but fewer studies have reported its effect on the duration of surgery. A study by Çataltepe and Öznam has reported a significant decrease in operation time in patients undergoing primary THA.26 Our study observed a statistically significant reduction in operative time with TXA administration compared to the non-TXA group (p = 0.046). This finding is important, as reduced operative time can potentially decrease the risk of intraoperative complications and improve overall surgical efficiency. Also, as there is limited data on the impact of TXA on operative time, our study adds valuable insight into this aspect, suggesting that TXA may have a role in enhancing surgical efficiency.
It has been reported that TXA attenuates early postoperative systemic inflammatory response and enhances recovery after THA.27 However, the influence of TXA on functional recovery parameters, such as the time to full weight-bearing, has not been extensively studied. In a study by Fraval et al., the blood-conserving effect of TXA was not linked to improved postoperative recovery in terms of pain and mobility.16 Current literature suggests that while TXA effectively reduces blood loss, it may not directly influence the speed of functional recovery. Given the limited data on the relationship between TXA use and postoperative functional recovery, our findings contribute to the understanding that while TXA is effective in reducing blood loss during total hip replacement, it does not appear to significantly affect the time to full weight-bearing postoperatively.
The differential efficacy of TXA between inflammatory arthritis (Rheumatoid Arthritis, RA) and degenerative arthritis (Osteoarthritis, OA) in THR surgery may be attributed to distinct pathophysiological mechanisms. Inflammatory arthritis is characterized by chronic systemic inflammation and synovial hyperplasia, which leads to increased vascularity and periarticular tissue friability, contributing to greater intraoperative blood loss and higher transfusion rates compared to degenerative arthritis.8, 9, 10 The inflammatory environment elevates pro-inflammatory cytokines such as interleukin-1 (IL-1) and interleukin-6 (IL-6) in patients with inflammatory arthritis, which can disrupt the balance between procoagulant and anticoagulant factors, potentially altering hemostatic responses.8 These alterations may impair the antifibrinolytic efficacy of TXA by modifying fibrinolysis or affecting coagulation pathways.8 In contrast, degenerative arthritis is primarily a non-inflammatory degenerative condition characterized by cartilage degradation, subchondral bone remodeling, and osteophyte formation.11,12 While localized inflammation may occur, systemic inflammatory markers are typically absent or minimally elevated. The hemostatic profile in OA patients undergoing THR is generally more stable, with fewer alterations in coagulation pathways.8,11,12 Consequently, TXA appears to function more effectively in degenerative arthritis patients, consistently reducing perioperative blood loss and transfusion requirements.8 Studies have demonstrated that while TXA reduces blood loss in inflammatory arthritis patients undergoing total joint arthroplasty, its impact on transfusion rates is less pronounced, suggesting a more complex interaction between inflammation and coagulation in inflammatory arthritis.10 These differences observed between inflammatory and degenerative hip arthritis in terms of TXA efficacy in reducing blood loss during THR have also been reflected in the outcomes of our study, with a more pronounced effect observed in the degenerative hip arthritis cohort. The higher intraoperative blood loss observed in inflammatory arthritis patients, despite normal PT/INR and bleeding/clotting times, may be attributed to synovial hyperplasia and friable periarticular tissues observed during the surgeries.
THA is generally associated with favorable outcomes; however, various complications can occur postoperatively. Dislocation rates have been reported between 1 % and 3 %, with most incidents occurring within the first three months after surgery.28,29 Infection rates are approximately 1 %, with deep infections being particularly concerning due to their potential severity.28,29 Aseptic loosening remains a leading cause of long-term failure in THA, often necessitating revision surgery. Intraoperative fractures, especially iatrogenic ones, are relatively rare but can complicate the surgical course and recovery.29 Advancements in implant materials and techniques have contributed to reduced osteolysis rates.30 Findings of our study align with reported complication rates in the literature. Also, no safety signals were reported in our study population, which is consistent with published literature.
Our study has several limitations. The retrospective design may introduce selection bias. Unmeasured confounding variables, such as surgeon experience and co-morbid conditions, may also influence the results. The small sample size may also have affected the significance levels of the outcomes. Additionally, the findings may be less generalizable to other populations due to the single-center setting and the specific Indian dietary and racial factors influencing its fibrinolytic activity. Although the surgeries were performed according to standardized institutional protocol, sensitivity analyses were not performed to assess the impact of surgeon variability on the primary and secondary outcomes, as surgeon-related variability could be a potential confounding factor in differential outcomes.
Fibrinolytic activity varies across populations due to factors such as racial differences and dietary habits. Indian diets, rich in onions, chilies, and spices, have been shown to enhance fibrinolytic activity.5 A study found that incorporating these spices with a fatty meal significantly increased fibrinolytic activity in healthy subjects.31 These differences in fibrinolytic activity may lead to variations in bleeding tendencies and influence the efficacy of antifibrinolytic agents like TXA in the Indian population. A study found that the use of antifibrinolytic during hip surgeries significantly lowered the length of hospital days as compared to the non-antifibrinolytic group.32 Despite these limitations, our study provides valuable insights into the efficacy of TXA in diverse arthritis populations undergoing THR. The significant reduction in operative time, combined with the observed trends toward reduced blood loss and drain output, suggests that TXA may not only mitigate perioperative bleeding but also enhance surgical workflow and recovery. Future studies with larger sample sizes and possibly randomized controlled trials are warranted to validate the findings of our study. Based on the observed difference in intraoperative blood loss between TXA and non-TXA groups in this study, a future study would require an estimated sample size of 192 patients per group.
5. Conclusion
This study demonstrates that tranexamic acid effectively reduces operative time in total hip replacement surgeries for patients with both inflammatory and degenerative hip arthritis. However, its impact on intraoperative blood loss and drain output was not statistically significant. TXA use also had no significant effect on functional outcomes measured by time to full weight-bearing. While subgroup analyses suggest a potentially greater but statistically non-significant benefit for patients with degenerative arthritis in terms of blood loss, drain output, operative time, and functional outcomes. These findings highlight the importance of considering the underlying type of arthritis when evaluating the efficacy of TXA. Future research with larger sample sizes and multicenter collaborations, preferably through randomized controlled trials, is required to validate these findings and further investigate the mechanisms underlying the differential responses between inflammatory and degenerative arthritis patients.
CRediT authorship contribution statement
Mohabey Ankush: Conceptualization, study design, data collection, manuscript drafting, and final approval. Sah Saurabh: Formal analysis, statistical interpretation, manuscript writing, and critical revision. Dwidmuthe Samir: Methodology, literature review, Writing – review & editing, and supervision. Kotangale Pratik: Validation, manuscript review, and final approval. Sahare Pratik: Validation, manuscript review, and final approval.
Ethical statement
This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and was approved by the Institutional Ethics Committee (Approval No: 2024-171, Date: December 20, 2024). There are no conflicts of interest or ethical concerns related to this study.
Patient consent in a retrospective cohort study
As per standard ethical guidelines, including those outlined by the Declaration of Helsinki and institutional review boards (IRBs), written informed consent has been obtained from the patient or guardian for participation and publication.
Funding statement
No external funding was received by any of the authors during this project.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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