BIOSURE™ RG Knee Safety & Performance Study

ACL Repair Clinical Trial

Official title: Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction

Status Completed

Clinical Trial Summary

Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction

Clinical Trial Description

This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following:

Knee repair:

• ACL repair Posterior cruciate ligament (PCL) repair

• Extra-capsular repairs

• Medial collateral ligament (MCL)

• Lateral collateral ligament (LCL)

• Posterior oblique ligament (POL)

• Patellar realignment and tendon repairs

• Vastus medialis obliquus advancement

• Iliotibial band tenodesis ;

Related Conditions & MeSH terms

• ACL Repair
• Extra-capsular Repairs
• Iliotibial Band Tenodesis
• Knee Repair
• Lateral Collateral Ligament (LCL)
• Medial Collateral Ligament (MCL)
• Patellar Realignment and Tendon Repairs
• Posterior Cruciate Ligament (PCL) Repair
• Posterior Oblique Ligament (POL)
• Vastus Medialis Obliquus Advancement

• NCT number: NCT03519555
• Study type: Observational
• Source: Smith & Nephew, Inc.
• Status: Completed
• Start date: November 9, 2017
• Completion date: October 5, 2020