Evaluation of the Effect of SURGICEL® Powder in TKA

Phase 4RecruitingNCT06608992

Peking University Third Hospital112 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Interventions

SURGICEL® PowderDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 day after surgery

total perioperative blood loss

Time frame: 2 days after surgery

total perioperative blood loss

Time frame: 3 days after surgery

total perioperative blood loss

Time frame: 4 days after surgery

total perioperative blood loss

Time frame: 5 days after surgery

Secondary Outcomes

pain visual analogue scale score

pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 5 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

Time frame: 2 weeks 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.

Time frame: 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.

Time frame: Postoperative day 2

Central Contacts

Hua Tian, doctor

CONTACT

86-18811185091 tianhua@bjmu.edu.cn

Guo Wei Zhang, bachelor

CONTACT

86-18811778038 2011210412@pku.edu.cn

Data from ClinicalTrials.gov

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Limb Swelling Rate

(Postoperative circumference 10 cm above the patella - Preoperative circumference 10 cm above the patella) / Preoperative circumference 10 cm above the patella.

Time frame: 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.

Time frame: 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.

Time frame: Postoperative day 5

Coagulation Testing

Assay index including D-dimers and Activated partial thromboplastin time.

Time frame: Postoperative day 1

Coagulation Testing

Assay index including D-dimers and Activated partial thromboplastin time.

Time frame: Postoperative day 2

Coagulation Testing

Assay index including D-dimers and Activated partial thromboplastin time.

Time frame: Postoperative day 3

Coagulation Testing

Assay index including D-dimers and Activated partial thromboplastin time.

Time frame: Postoperative day 4

Coagulation Testing

Assay index including D-dimers and Activated partial thromboplastin time.

Time frame: Postoperative day 5

Knee range of motion