Jewel ACL Post Market Clinical Follow Up Study

The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Med-Polonia

Poznan, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age more than 18 years
Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases)

Exclusion criteria

Age less than 18 years
Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU)
Revision cases

Treatment and study plan

JewelACL

Device

The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction

Primary outcomes

Occurrence of Re-ruptures

Time frame: Five Year

Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction

Sponsors and collaborators

Lead sponsor

Xiros Ltd

Industry

Registry information

Official study title

The JewelACL Post Market Clinical Follow Up Study - Multicentre Study of at Least 5 Years Follow up, Looking at Clinical Outcomes in Patients Treated With the JewelACL for Anterior Cruciate Ligament (ACL) Reconstruction

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Oct 8, 2020
Registry last updated: Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed