NCT03305887

Symmetric on Total Knee Arthroplasty (TKA)

A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Johnson & Johnson Medical, China · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Wound Closure

Interventions

Type	Name	Description
DEVICE	"STRATAFIX™ Symmetric" Knotless Tissue	This devices will be used in deep and intermediate layers of barbed suture group.
DEVICE	VICRYL® PLUS	This devices will be used in deep and intermediate layers of conventional suture group.
DEVICE	"STRATAFIX Spiral" sutures	This devices will be used in intradermal layer of both barbed suture and conventional suture group.
DEVICE	DERMABOND™ Advance™ Skin Closure System	This devices will be used in skin layer of both barbed suture and conventional suture group.

Timeline

• Start date: 2017-06-12
• Primary completion: 2018-04-13
• Completion: 2018-05-21
• First posted: 2017-10-10
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

7 sites across 1 country: China

Regulatory

• FDA-regulated device study