Jewel ACL Post Market Clinical Follow Up Study

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Device: JewelACL

• Registration Number: NCT04580290
• Lead Sponsor: Xiros Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-08
• Primary Completion: 2021-04-09
• Study Completion: 2021-04-09
• Results First Submitted: 2021-08-31
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Results First Posted: 2021-11-02
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JewelACL only	JewelACL	JewelACL only
JewelACL + Autograft (Hybrid)	JewelACL	JewelACL + Autograft (Hybrid)

Primary Outcome Measures

Name	Time	Method
Occurrence of Re-ruptures	Five Year	Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction

Trial Locations

Locations (1)

Med-Polonia; 🇵🇱 Poznań, Poland