Menu
Recruiting NCT06608992

Evaluation of the Effect of SURGICEL® Powder in TKA

Phase IV Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SURGICEL® Powder.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug SURGICEL® 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

Primary outcome measures

  • total perioperative blood loss [Time frame: 1 day after surgery]
  • total perioperative blood loss [Time frame: 2 days after surgery]
  • total perioperative blood loss [Time frame: 3 days after surgery]
  • total perioperative blood loss [Time frame: 4 days after surgery]
  • total perioperative blood loss [Time frame: 5 days after surgery]
Secondary outcome measures (12)
  • pain visual analogue scale score [Time frame: 1 day after surgery]
  • pain visual analogue scale score [Time frame: 2 days after surgery]
  • pain visual analogue scale score [Time frame: 3 days after surgery]
  • pain visual analogue scale score [Time frame: 4 days after surgery]
  • pain visual analogue scale score [Time frame: 5 days after surgery]
  • pain visual analogue scale score [Time frame: 2 weeks after surgery]
  • Limb Swelling Rate [Time frame: Postoperative day 1]
  • Limb Swelling Rate [Time frame: Postoperative day 2]
  • Limb Swelling Rate [Time frame: Postoperative day 3]
  • Limb Swelling Rate [Time frame: Postoperative day 4]
  • Limb Swelling Rate [Time frame: Postoperative day 5]
  • Coagulation Testing [Time frame: Postoperative day 1]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT06608992 · SP-TKA-RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗