Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA：a Randomized Controlled Trial
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.
• 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.