Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA：a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- SURGICEL® Powder
- Conditions
- Not specified
- Sponsor
- Peking University Third Hospital
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- total perioperative blood loss
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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 (on postoperative days 3 and 5), intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate (postoperative days 1-5), postoperative limb pain (measured by the Visual Analogue Scale, VAS, on days 1-5), and range of motion (ROM on days 1-5). 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
using SURGICEL® Powder
The SURGICEL® Powder will be sprayed in areas such as the posterior joint capsule, medial gap, lateral gap, suprapatellar pouch, and infrapatellar fat pad. After the SURGICEL® Powder fully react and change color, any unreacted SURGICEL® Powder will be appropriately washed using an irrigation gun.
Intervention: SURGICEL® Powder
Outcomes
Primary Outcomes
total perioperative blood loss
Time Frame: 5 days after surgery
Total Blood Loss = Preoperative Blood Volume (PBV) × (Preoperative Hematocrit - Postoperative Hematocrit) / Average Hematocrit + Transfusion Volume Where: Average Hematocrit = (Preoperative Hematocrit + Postoperative Hematocrit) / 2 PBV is calculated using Nadler's method: PBV = K1 × Height (m)³ + K2 × Weight (kg) + K3 For males: K1 = 0.3669, K2 = 0.03219, K3 = 0.6041 For females: K1 = 0.3561, K2 = 0.03308, K3 = 0.1833；The lower it is, the better the hemostatic effect.
Secondary Outcomes
- Blood routine(Postoperative day 5)
- pain visual analogue scale score(2 weeks after surgery)
- Knee range of motion(Postoperative day 14)
- Limb Swelling Rate(Postoperative day 5)
- Coagulation Testing(Postoperative day 5)