Evaluation of the Effect of SURGICEL® Powder in TKA

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• total perioperative blood loss [Срок оценки: 1 day after surgery]
• total perioperative blood loss [Срок оценки: 2 days after surgery]
• total perioperative blood loss [Срок оценки: 3 days after surgery]
• total perioperative blood loss [Срок оценки: 4 days after surgery]
• total perioperative blood loss [Срок оценки: 5 days after surgery]

Вторичные конечные точки (12)

• pain visual analogue scale score [Срок оценки: 1 day after surgery]
• pain visual analogue scale score [Срок оценки: 2 days after surgery]
• pain visual analogue scale score [Срок оценки: 3 days after surgery]
• pain visual analogue scale score [Срок оценки: 4 days after surgery]
• pain visual analogue scale score [Срок оценки: 5 days after surgery]
• pain visual analogue scale score [Срок оценки: 2 weeks after surgery]
• Limb Swelling Rate [Срок оценки: Postoperative day 1]
• Limb Swelling Rate [Срок оценки: Postoperative day 2]
• Limb Swelling Rate [Срок оценки: Postoperative day 3]
• Limb Swelling Rate [Срок оценки: Postoperative day 4]
• Limb Swelling Rate [Срок оценки: Postoperative day 5]
• Coagulation Testing [Срок оценки: Postoperative day 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06608992 · SP-TKA-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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