140
Participants
Start Date
December 17, 2019
Primary Completion Date
September 11, 2021
Study Completion Date
November 9, 2022
Investigational device: Biosure Regenesorb Interference Screw
The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing.
Control device: BIOSURE HA Interference Screw
BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion.
Peking University Third Hospital, Beijing
The Third Xiangya Hospital of Central South University, Changsha
The Third Affiliated Hospital of Southern Medical University, Guangzhou
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
Smith & Nephew, Inc.
INDUSTRY