FastThread Interference Screws

Status Recruiting

Clinical Trial Summary

Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.

Clinical Trial Description

The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only). To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality. ;

Study Design

Related Conditions & MeSH terms

ACL Injury
Anterior Cruciate Ligament Injuries

Clinical Trial Details

NCT number	NCT04689061
Study type	Observational [Patient Registry]
Source	Arthrex, Inc.
Contact	Samantha Martino
Phone	800.933.7001
Email	samantha.martino@arthrex.com
Status	Recruiting
Phase
Start date	August 31, 2020
Completion date	August 2023

View Details

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