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Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL ae Powder in Total Knee Arthroplasty A Randomized Controlled Trial
Led by Peking University Third Hospital · Updated on 2025-02-12
112
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. This prospective, parallel randomized controlled trial will include 112 participants divided into two groups to evaluate the effects of SURGICEL ae Powder on blood loss and other surgical outcomes. The study aims to provide recommendations on the clinical use of SURGICEL ae Powder by assessing its hemostatic properties during TKA. Participants will be randomly assigned to either receive SURGICEL ae Powder applied to specific knee areas during surgery or to a group where SURGICEL ae Powder is not used. The powder is sprayed on areas such as the posterior joint capsule and fat pad, and after its reaction, unreacted powder is washed away. The other group will undergo surgery without the use of SURGICEL ae Powder, allowing comparison between the two approaches. During the study, researchers will monitor total perioperative blood loss from days 1 to 5 after surgery, intraoperative blood loss, transfusion rates and volumes, postoperative declines in hemoglobin and hematocrit, limb swelling rates, pain levels measured by the Visual Analogue Scale (VAS), and knee range of motion over the first five days. Blood routine tests and coagulation testing will also be performed. This detailed monitoring will help assess the safety and effectiveness of SURGICEL ae Powder in supporting recovery after TKA.
CONDITIONS
Brief Title
Evaluation of the Effect of SURGICEL® Powder in TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary knee osteoarthritis with Kellgren-Lawrence stage III or higher confirmed by symptoms, physical exam, and imaging
- Experiencing severe knee pain with functional limits unresponsive to conservative treatment
- Scheduled for unilateral primary total knee arthroplasty
- No severe knee deformity: flexion deformity ≤30°, varus ≤20°, valgus ≤10°
- Undergoing manual surgery with traditional instruments
You will not qualify if you...
- History of long-term anticoagulant use over 3 months or failure to stop certain medications before surgery
- 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 recent coronary stent placement
- Severe respiratory disease with lung function limits
- History or high risk of venous thromboembolism or coagulation disorders
- Stroke or history of malignant tumors
- Anemia according to WHO criteria (Hb <130 g/L for males, <120 g/L for females)
- Undergoing TKA with robotic or navigation assistance
- Other contraindications to total knee arthroplasty such as metal allergies
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo unilateral primary total knee arthroplasty, during which SURGICEL® Powder may be applied to specific areas to help control bleeding, or no hemostatic powder is used depending on group assignment.
1 surgical visit (in-person)
Duration - 5 days
Participants are monitored for blood loss, pain, limb swelling, range of motion, and other clinical assessments during the first 5 days after surgery.
Daily visits for 5 days (in-person)
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100181
Actively Recruiting
Research Team
H
Hua Tian, doctor
G
Guo Wei Zhang, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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