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NCT Number: NCT06608992

Evaluation of the Effect of SURGICEL® Powder in TKA

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. total perioperative blood loss

    Time frame: 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.

  2. total perioperative blood loss

    Time frame: 2 days 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.

  3. total perioperative blood loss

    Time frame: 3 days 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.

  4. total perioperative blood loss

    Time frame: 4 days 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.

  5. total perioperative blood loss

    Time frame: 5 days 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 outcomes

  1. pain visual analogue scale score

    Time frame: 1 day after surgery

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

  2. pain visual analogue scale score

    Time frame: 2 days after surgery

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

  3. pain visual analogue scale score

    Time frame: 3 days after surgery

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

  4. pain visual analogue scale score

    Time frame: 4 days after surgery

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

  5. pain visual analogue scale score

    Time frame: 5 days after surgery

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

  6. pain visual analogue scale score

    Time frame: 2 weeks after surgery

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

  7. Limb Swelling Rate

    Time frame: Postoperative day 1

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

  8. Limb Swelling Rate

    Time frame: Postoperative day 2

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

  9. Limb Swelling Rate

    Time frame: Postoperative day 3

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

  10. Limb Swelling Rate

    Time frame: Postoperative day 4

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

  11. Limb Swelling Rate

    Time frame: Postoperative day 5

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

  12. Coagulation Testing

    Time frame: Postoperative day 1

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

  13. Coagulation Testing

    Time frame: Postoperative day 2

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

  14. Coagulation Testing

    Time frame: Postoperative day 3

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

  15. Coagulation Testing

    Time frame: Postoperative day 4

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

  16. Coagulation Testing

    Time frame: Postoperative day 5

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

  17. Knee range of motion

    Time frame: Postoperative day 1

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  18. Knee range of motion

    Time frame: Postoperative day 2

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  19. Knee range of motion

    Time frame: Postoperative day 3

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  20. Knee range of motion

    Time frame: Postoperative day 4

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  21. Knee range of motion

    Time frame: Postoperative day 5

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  22. Knee range of motion

    Time frame: Postoperative day 14

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  23. Blood routine

    Time frame: Postoperative day 1

    Assay index including white blood cell count and neutrophil count.

  24. Blood routine

    Time frame: Postoperative day 2

    Assay index including white blood cell count and neutrophil count.

  25. Blood routine

    Time frame: Postoperative day 3

    Assay index including white blood cell count and neutrophil count.

  26. Blood routine

    Time frame: Postoperative day 4

    Assay index including white blood cell count and neutrophil count.

  27. Blood routine

    Time frame: Postoperative day 5

    Assay index including white blood cell count and neutrophil count.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo Wei Zhang, bachelor

CONTACT

[email protected]

86-18811778038

Hua Tian, doctor

CONTACT

[email protected]

86-18811185091

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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