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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| using SURGICEL® Powder | Experimental | 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. |
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| not using SURGICEL® Powder | No Intervention | The SURGICEL® Powder will not be used during the surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SURGICEL® Powder | Drug | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Tian, doctor | Contact | 86-18811185091 | tianhua@bjmu.edu.cn | |
| Guo Wei Zhang, bachelor | Contact | 86-18811778038 | 2011210412@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hua Tian, doctor | Director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100181 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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 ).
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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.
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| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 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 |
| 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 |
| D012216 |
| Rheumatic Diseases |