Clinical trial NCT06608992: Evaluation of the Effect of SURGICEL® Powder in TKA
Official title: Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
knee osteoarthritis
SURGICEL® Powder
the safety and hemostatic effectiveness
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to the inclusion/exclusion criteria for study participants, patients undergoing unilateral primary total knee arthroplasty will be screened. After obtaining informed consent from the patients, computer-based randomization will be conducted. The patients included in the study will be randomly assigned to either the test group (using SURGICEL® Powder ) or the control group (not using SURGICEL® Powder ).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: total perioperative blood loss
timeFrame: 1 day after surgery
measure: total perioperative blood loss
timeFrame: 2 days after surgery
measure: total perioperative blood loss
timeFrame: 3 days after surgery
measure: total perioperative blood loss
timeFrame: 4 days after surgery
measure: total perioperative blood loss
timeFrame: 5 days after surgery
Secondary outcomes:
measure: pain visual analogue scale score
timeFrame: 1 day after surgery
measure: pain visual analogue scale score
timeFrame: 2 days after surgery
measure: pain visual analogue scale score
timeFrame: 3 days after surgery
measure: pain visual analogue scale score
timeFrame: 4 days after surgery
measure: pain visual analogue scale score
timeFrame: 5 days after surgery
measure: pain visual analogue scale score
timeFrame: 2 weeks after surgery
measure: Limb Swelling Rate
timeFrame: Postoperative day 1
measure: Limb Swelling Rate
timeFrame: Postoperative day 2
measure: Limb Swelling Rate
timeFrame: Postoperative day 3
measure: Limb Swelling Rate
timeFrame: Postoperative day 4
measure: Limb Swelling Rate
timeFrame: Postoperative day 5
measure: Coagulation Testing
timeFrame: Postoperative day 1
measure: Coagulation Testing
timeFrame: Postoperative day 2
measure: Coagulation Testing
timeFrame: Postoperative day 3
measure: Coagulation Testing
timeFrame: Postoperative day 4
measure: Coagulation Testing
timeFrame: Postoperative day 5
measure: Knee range of motion
timeFrame: Postoperative day 1
measure: Knee range of motion
timeFrame: Postoperative day 2
measure: Knee range of motion
timeFrame: Postoperative day 3
measure: Knee range of motion
timeFrame: Postoperative day 4
measure: Knee range of motion
timeFrame: Postoperative day 5
measure: Knee range of motion
timeFrame: Postoperative day 14
measure: Blood routine
timeFrame: Postoperative day 1
measure: Blood routine
timeFrame: Postoperative day 2
measure: Blood routine
timeFrame: Postoperative day 3
measure: Blood routine
timeFrame: Postoperative day 4
measure: Blood routine
timeFrame: Postoperative day 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Director
name: Hua Tian, doctor
role: STUDY_CHAIR
References: