Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese

NACompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

December 17, 2019

Primary Completion Date

September 11, 2021

Study Completion Date

November 9, 2022

Conditions
Cruciate Ligament ReconstructionKnee
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (4)

100191

Peking University Third Hospital, Beijing

410000

The Third Xiangya Hospital of Central South University, Changsha

510000

The Third Affiliated Hospital of Southern Medical University, Guangzhou

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

All Listed Sponsors
lead

Smith & Nephew, Inc.

INDUSTRY

NCT04012567 - Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese | Biotech Hunter | Biotech Hunter