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NCT04580290 Clinical Trial

Jewel ACL Post Market Clinical Follow Up Study

Anterior Cruciate Ligament Injuries Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04580290
Other study ID # CRE 027
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2, 2020
Est. completion date April 9, 2021

Study information
Verified date October 2021
Source Xiros Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 9, 2021
Est. primary completion date April 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Intervention

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

Locations
Country Name City State
Poland Med-Polonia Poznan

Sponsors (1)
Lead Sponsor Collaborator
Xiros Ltd

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of Re-ruptures Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction Five Year
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