Osteoarthritis, Knee
Conditions
Keywords
Arthroplasty, Replacement, Knee Tranexamic Acid Blood Loss, Surgical Drainage Perioperative Care Hemostasis, Surgical Randomized Controlled Trial
Brief summary
This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. A total of 192 patients will be randomly assigned to three groups: Group 1 will receive TNA with suction drainage, Group 2 will receive TNA only, and Group 3 will receive suction drainage only. The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.
Detailed description
Total knee arthroplasty (TKA) is commonly associated with significant perioperative blood loss, which may increase transfusion requirements and associated risks such as immunologic reactions, infection, and delayed recovery. Tranexamic acid (TNA) is an antifibrinolytic agent that inhibits fibrinolysis by blocking the activation of plasminogen. Suction drainage is frequently used to prevent hematoma formation, but its benefit in reducing transfusion needs remains controversial. This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively. The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.
Interventions
DRUGIntra-articular Tranexamic Acid + Suction Drainage
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively.
DRUGIntra-articular Tranexamic Acid
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.
DEVICESuction Drainage Only
Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.
Sponsors
Idlib University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not applicable. The study was conducted as an open-label trial with no blinded parties.
Intervention model description
\> This is a prospective randomized clinical trial including 192 patients undergoing total knee arthroplasty. Participants were randomly assigned to one of three groups to assess the effects of intra-articular tranexamic acid and/or suction drainage on total and hidden blood loss, transfusion requirements, postoperative limb swelling, wound-related complications, and knee range of motion.
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with degenerative knee arthritis * Scheduled for unilateral total knee arthroplasty
Exclusion criteria
* Rheumatoid arthritis * Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events) * Coagulation disorders or thromboembolic disorders * Severe infections * Other serious health issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Loss | Within 72 hours after surgery | Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drainage Volume | 24 hours postoperatively | Total drainage collected through suction drains when applicable. |
| Number of Blood Transfusions | During hospital stay (up to 7 days postoperatively) | Number of patients receiving blood transfusions based on NIH Consensus criteria (Hb \< 8.0 g/dL, or \<10.0 g/dL with symptoms). |
| Postoperative Limb Swelling | 1, 2, 4, and 6 weeks postoperatively | Change in limb circumference at thigh, knee, and calf compared with preoperative baseline. |
| Hidden Blood Loss | Within 72 hours after surgery | Hidden blood loss calculated as total blood loss minus drainage volume. |
| Thromboembolic Events (DVT/PE) | Within 6 weeks after surgery | Incidence of deep vein thrombosis (DVT) confirmed with Doppler ultrasonography and pulmonary embolism (PE) if suspected clinically. |
| Postoperative Knee Range of Motion | 2 months postoperatively | Range of motion measured with a goniometer (flexion and extension). |
| Wound-related Complications | Within 6 weeks after surgery | Incidence of wound-related issues, including infection, hematoma, erythema, or superficial wound complications. |
Countries
Syria
Outcome results
None listed