Evaluating SURGICEL® Powder for knee surgery

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

This study is testing if using SURGICEL® Powder during knee surgery can help reduce blood loss and improve recovery for people getting a knee replacement due to arthritis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06608992 on ClinicalTrials.gov

What this trial studies

This study involves patients undergoing unilateral primary total knee arthroplasty (TKA) due to knee osteoarthritis. It is a prospective, parallel randomized controlled trial with 112 participants divided into two groups: one receiving SURGICEL® Powder and the other not. The study aims to compare various outcomes such as blood loss, transfusion rates, hemoglobin and hematocrit changes, limb swelling, pain levels, and range of motion post-surgery. Statistical analysis will be conducted to assess the hemostatic effectiveness of SURGICEL® Powder and provide clinical recommendations.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with primary knee osteoarthritis scheduled for unilateral TKA and experiencing severe knee pain unresponsive to conservative treatment.

Not a fit: Patients with severe knee deformities or those on long-term anticoagulant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing knee arthroplasty.

How similar studies have performed: Other studies have shown promising results with hemostatic agents in surgical settings, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with primary knee osteoarthritis based on symptoms, physical examination, and imaging, with X-ray showing Kellgren-Lawrence (K-L) stage III or higher.
2. Severe knee pain with functional limitations, unresponsive to conservative treatment, and scheduled for unilateral primary total knee arthroplasty (TKA).
3. No severe knee deformity (flexion deformity \>30°, varus \>20°, or valgus \>10°).
4. Patients undergoing manual surgery with traditional instruments.

Exclusion Criteria:

1. 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).
2. Patients undergoing TKA surgery with the assistance of robotic or navigation digital technology.
3. Presence of other contraindications to total knee arthroplasty, such as metal allergies.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hua Tian, doctor

Conditions Knee Osteoarthritis; total knee arthroplasty; knee osteoarthritis; SURGICEL® Powder; the safety and hemostatic effectiveness