Evaluation of the Effect of SURGICEL® Powder in TKA

Phase 4

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Drug: SURGICEL® Powder

• Registration Number: NCT06608992
• Lead Sponsor: Peking University Third Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-08-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
using SURGICEL® Powder	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.

Primary Outcome Measures

Name	Time	Method
total perioperative blood loss	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 Outcome Measures

Name	Time	Method
pain visual analogue scale score	2 weeks after surgery	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Limb Swelling Rate	Postoperative day 5	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.
Coagulation Testing	Postoperative day 5	Assay index including D-dimers and Activated partial thromboplastin time.
Knee range of motion	Postoperative day 14	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Blood routine	Postoperative day 5	Assay index including white blood cell count and neutrophil count.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China