Jewel ACL Post Market Clinical Follow Up Study
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
1 other identifier
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2020
CompletedFirst Submitted
Initial submission to the registry
October 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2021
CompletedResults Posted
Study results publicly available
November 2, 2021
CompletedNovember 2, 2021
October 1, 2021
6 months
October 5, 2020
August 31, 2021
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of Re-ruptures
Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction
Five Year
Study Arms (2)
JewelACL + Autograft (Hybrid)
JewelACL + Autograft (Hybrid)
JewelACL only
JewelACL only
Interventions
The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction
Eligibility Criteria
Consecutive patients who have had the JewelACL device used to reconstruct the ACL, between the period of 01 October 2010 to 31 December 2014.
You may qualify if:
- Age more than 18 years
- Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases)
You may not qualify if:
- Age less than 18 years
- Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU)
- Revision cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiros Ltdlead
Study Sites (1)
Med-Polonia
Poznan, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Reruptures can be sustained during sports trauma and cannot necessarily be attributed to device insufficiency.
Results Point of Contact
- Title
- Tracey Oxley
- Organization
- Xiros Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2020
First Posted
October 8, 2020
Study Start
October 2, 2020
Primary Completion
April 9, 2021
Study Completion
April 9, 2021
Last Updated
November 2, 2021
Results First Posted
November 2, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share