Actively Recruiting
Evaluation of the Effect of SURGICEL® Powder in TKA
Led by Peking University Third Hospital · Updated on 2025-02-12
112
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official 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 confirmed by symptoms, physical exam, and imaging with Kellgren-Lawrence stage III or higher
- Severe knee pain with functional limitations not improved by conservative treatment
- Scheduled for unilateral primary total knee arthroplasty (TKA)
- No severe knee deformity: flexion deformity ≤30°, varus ≤20°, and valgus ≤10°
- Undergoing manual surgery with traditional instruments
You will not qualify if you...
- History of long-term anticoagulant use >3 months for cardiovascular or cerebrovascular disease and inability to stop medication as required
- 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 last 12 months
- Severe respiratory disease: lung function FEV1.0 <0.5L or FEV1.0/FVC <60%
- History of venous thromboembolism or high risk of thrombosis
- Coagulation disorders: APTT ≥46 seconds or INR ≥1.7
- History of stroke or malignant tumors
- Anemia: Hb <130 g/L for males and <120 g/L for females
- Undergoing TKA with robotic or navigation digital assistance
- Contraindications to TKA such as metal allergies
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100181
Actively Recruiting
Research Team
H
Hua Tian, doctor
CONTACT
G
Guo Wei Zhang, bachelor
CONTACT
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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