Jewel ACL Post Market Clinical Follow Up Study

Xiros Ltd120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Anterior Cruciate Ligament Injuries

Interventions

JewelACLDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Med-Polonia

Poznan, Poland

Outcomes

Primary Outcomes

Occurrence of Re-ruptures

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

Time frame: Five Year

Data from ClinicalTrials.gov

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