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Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament

Knee Injuries Clinical Trial

Official title:
A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament

Clinical Trial Summary

The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.

Clinical Trial Description

The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02540811
Study type Interventional
Source Tissue Regenix Ltd
Contact
Status Completed
Phase N/A
Start date September 2015
Completion date August 11, 2021
View Details
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