Evaluation of the Effect of SURGICEL® Powder in TKA

Last updated: February 10, 2025
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Osteoarthritis

Knee Injuries

Treatment

SURGICEL® Powder

Clinical Study ID

NCT06608992
SP-TKA-RCT
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 conservativetreatment, 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

Exclusion Criteria:

  1. History of long-term anticoagulant use for more than 3 months due to cardiovascularor cerebrovascular disease and failure to stop medication (Aspirin/Clopidogrel <7days, Warfarin <5 days, or Reserpine <7 days), or the presence of the followingconditions: renal insufficiency (blood urea nitrogen ≥25.3 mmol/L or serumcreatinine ≥442 μmol/L), liver insufficiency (ALT or AST ≥80 U/L), severe heartdisease (or coronary stent placement within the last 12 months), severe respiratorydisease (lung function FEV1.0 <0.5L or FEV1.0/FVC <60%), history of venousthromboembolism (VTE) or high risk of thrombosis (hereditary/acquired thromboticdisorders), coagulation disorders (APTT ≥46 seconds or INR ≥1.7), stroke, or historyof malignant tumors; anemia (according to WHO anemia diagnosis criteria, Hb <130 g/Lfor males and <120 g/L for females).

  2. Patients undergoing TKA surgery with the assistance of robotic or navigation digitaltechnology.

  3. Presence of other contraindications to total knee arthroplasty, such as metalallergies.

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: SURGICEL® Powder
Phase: 4
Study Start date:
September 28, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100181
    China

    Active - Recruiting

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