Jewel ACL Post Market Clinical Follow Up Study

Xiros

Status: Completed

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: JewelACL

Study type: Observational

Funder types: Industry

Identifiers

NCT04580290

CRE 027

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

JewelACL + Autograft (Hybrid)

Description:

JewelACL + Autograft (Hybrid)

Treatment:

Device: JewelACL

JewelACL only

Description:

JewelACL only

Treatment:

Device: JewelACL