A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)
The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
184
This devices will be used in deep and intermediate layers of barbed suture group.
This devices will be used in deep and intermediate layers of conventional suture group.
This devices will be used in intradermal layer of both barbed suture and conventional suture group.
Chinese PLA general hospital
Beijing, Beijing Municipality, China
NanFang Hospital
Guangzhou, Guangdong, China
Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology
Wuhan, Hubei, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Suturing Time
The total time required to close the surgical incisions between treatment groups.
Time frame: During Surgery
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This devices will be used in skin layer of both barbed suture and conventional suture group.
Jilin University Chinese Japanese Friendship Hospital
Changchun, Jilin, China
second affiliated hospital of Xi'an Jiaotong university
Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China