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Evaluation of the Effect of SURGICEL® Powder in TKA

StatusRecruiting
PhasePhase 4
Started2024-09-28
View on ClinicalTrials.gov ↗
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.

Amendment history

2025-02-10
Study Status v1
Start date2024-08-30→2024-09-28
2024-09-19
Original filing
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.
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