Evaluation of the Effect of SURGICEL® Powder in TKA
Recruiting · NCT06608992 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University Third Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The study subjects are patients in our hospital's orthopedics department undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. Through a prospective, parallel randomized controlled study, 112 participants will be divided into two groups: the SURGICEL® Powder group and the non-use group. The study will compare the total perioperative blood loss , intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate , postoperative limb pain , and range of motion. Statistical analysis will be performed on the data to observe the hemostatic effects of SURGICEL® Powder, providing recommendations for the clinical use of SURGICEL® Powder.
Who can take part
Inclusion criteria
- Diagnosed with primary knee osteoarthritis based on symptoms, physical examination, and imaging, with X-ray showing Kellgren-Lawrence (K-L) stage III or higher.
- Severe knee pain with functional limitations, unresponsive to conservative treatment, and scheduled for unilateral primary total knee arthroplasty (TKA).
- No severe knee deformity (flexion deformity \>30°, varus \>20°, or valgus \>10°).
- Patients undergoing manual surgery with traditional instruments.
Exclusion criteria
- History of long-term anticoagulant use for more than 3 months due to cardiovascular or cerebrovascular disease and failure to stop medication (Aspirin/Clopidogrel \<7 days, Warfarin \<5 days, or Reserpine \<7 days), or the presence of the following conditions: renal insufficiency (blood urea nitrogen ≥25.3 mmol/L or serum creatinine ≥442 μmol/L), liver insufficiency (ALT or AST ≥80 U/L), severe heart disease (or coronary stent placement within the last 12 months), severe respiratory disease (lung function FEV1.0 \<0.5L or FEV1.0/FVC \<60%), history of venous thromboembolism (VTE) or high risk of thrombosis (hereditary/acquired thrombotic disorders), coagulation disorders (APTT ≥46 seconds or INR ≥1.7), stroke, or history of malignant tumors; anemia (according to WHO anemia diagnosis criteria, Hb \<130 g/L for males and \<120 g/L for females).
- Patients undergoing TKA surgery with the assistance of robotic or navigation digital technology.
- Presence of other contraindications to total knee arthroplasty, such as metal allergies.
Where it is running
1 location listed.
- Peking University Third Hospital - Beijing, Beijing Municipality, China