Evaluation of the Effect of SURGICEL® Powder in TKA

NCT06608992 | Recruiting Phase 4

• 1 other identifier: SP-TKA-RCT
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplasty; knee osteoarthritis; SURGICEL® Powder; the safety and hemostatic effectiveness

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (27)

• pain visual analogue scale score

  1 day after surgery

• pain visual analogue scale score

  2 days after surgery

• pain visual analogue scale score

  3 days after surgery

• pain visual analogue scale score

  4 days after surgery

• pain visual analogue scale score

  5 days after surgery

Study Arms (2)

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.

Drug: SURGICEL® Powder

not using SURGICEL® Powder

NO INTERVENTION

The SURGICEL® Powder will not be used during the surgery.

Interventions

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.

using SURGICEL® Powder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100181, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hua Tian, doctor

  Director

  STUDY CHAIR

Central Study Contacts

Hua Tian, doctor

CONTACT

86-18811185091; tianhua@bjmu.edu.cn

Guo Wei Zhang, bachelor

CONTACT

86-18811778038; 2011210412@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 ).

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 28, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)