Status:
RECRUITING
Evaluation of the Effect of SURGICEL® Powder in TKA
Lead Sponsor:
Peking University Third Hospital
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
Phase:
PHASE4
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 rand...
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06608992
Start Date
September 28 2024
End Date
September 1 2025
Last Update
February 12 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100181