Evaluation of the Effect of SURGICEL® Powder in TKA

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hua Tian, doctor; Phone Number: 86-18811185091; Email: tianhua@bjmu.edu.cn
• Study Contact Backup: Name: Guo Wei Zhang, bachelor; Phone Number: 86-18811778038; Email: 2011210412@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100181
      • Recruiting
      • Peking University Third Hospital
      • Contact: Hua Tian, doctor; Phone Number: 86-18811185091; Email: tianhua@bjmu.edu.cn
      • Contact: Guo Wei Zhang, bachelor; Phone Number: 86-18811778038; Email: 2011210412@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: using 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.	Drug: SURGICEL® Powder; SURGICEL® Powder are hemostatic product made of compacted, regenerated oxidized cellulose fine fiber aggregates, produced using a patented process. These particles are pre-loaded into an applicator device for application to the target bleeding site. SURGICEL® Powder are white with a slight yellow tint and have a faint caramel-like scent.When SURGICEL® Powder are fully saturated with blood, they expand into a brown or black gel-like substance that helps form a blood clot. This substance acts as a hemostatic adjunct to control localized bleeding.
No Intervention: not using SURGICEL® Powder; The SURGICEL® Powder will not be used during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total perioperative blood loss	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.	1 day after surgery
total perioperative blood loss	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.	2 days after surgery
total perioperative blood loss	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.	3 days after surgery
total perioperative blood loss	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.	4 days after surgery
total perioperative blood loss	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.	5 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 1
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 2
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 3
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	2 weeks after surgery
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 1
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 2
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 3
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	1 day after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	2 days after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	3 days after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	4 days after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	5 days after surgery
Limb Swelling Rate	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.	Postoperative day 1
Limb Swelling Rate	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.	Postoperative day 2
Limb Swelling Rate	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.	Postoperative day 3
Limb Swelling Rate	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.	Postoperative day 4
Limb Swelling Rate	(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.	Postoperative day 5
Coagulation Testing	Assay index including D-dimers and Activated partial thromboplastin time.	Postoperative day 1
Coagulation Testing	Assay index including D-dimers and Activated partial thromboplastin time.	Postoperative day 2
Coagulation Testing	Assay index including D-dimers and Activated partial thromboplastin time.	Postoperative day 3
Coagulation Testing	Assay index including D-dimers and Activated partial thromboplastin time.	Postoperative day 4
Coagulation Testing	Assay index including D-dimers and Activated partial thromboplastin time.	Postoperative day 5
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 4
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 5
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 14
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 4
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 5

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Hua Tian, doctor, Director

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: knee osteoarthritis; total knee arthroplasty; SURGICEL® Powder; the safety and hemostatic effectiveness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SP-TKA-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No