Knee Osteoarthritis
Conditions
Keywords
total knee arthroplasty, knee osteoarthritis, SURGICEL® Powder, the safety and hemostatic effectiveness
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.
Interventions
DRUGSURGICEL® 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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
During the trial, patients will not be aware of which hemostatic method corresponds to their assigned group. Except for the operating surgeon, the perioperative assessment of various parameters for the patients will be conducted by a medical team that is also unaware of the intraoperative hemostatic method used for the patient. Thus, the study achieves both patient blinding and assessor blinding, except for the surgeon. Unblinding will occur after the finalization of the statistical analysis plan, data audit report, and database lock, at which point the group assignment corresponding to the treatment group will be revealed. In emergency situations, if the researcher believes that revealing the intraoperative method used would benefit the handling of adverse events, emergency unblinding may occur.
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 ).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total perioperative blood loss | 1 day 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
| Measure | Time frame | Description |
|---|---|---|
| pain visual analogue scale score | 1 day 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 1 | (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 1 | Assay index including D-dimers and Activated partial thromboplastin time. |
| Knee range of motion | Postoperative day 1 | The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery |
| Blood routine | Postoperative day 1 | Assay index including white blood cell count and neutrophil count. |
Countries
China
Contacts
Primary ContactHua Tian, doctor
Backup ContactGuo Wei Zhang, bachelor
Outcome results
None listed