Clinical Trial

Evaluation of the Effect of SURGICEL® Powder in TKA

Recruiting Phase 4
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Record status
This record was last updated February 12, 2025 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-19.
Trial Details
NCT Number NCT06608992
Lead Sponsor Peking University Third Hospital
Conditions Knee Osteoarthritis
Enrollment 112 participants
Start Date 2024-09-28
Primary Completion 2025-08 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-02-12