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Jewel ACL Post Market Clinical Follow Up Study

NCT ID: NCT04580290

Last Updated: 2021-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-02

Study Completion Date

2021-04-09

Brief Summary

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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

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Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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JewelACL + Autograft (Hybrid)

JewelACL + Autograft (Hybrid)

JewelACL

Intervention Type DEVICE

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

JewelACL only

JewelACL only

JewelACL

Intervention Type DEVICE

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

Interventions

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JewelACL

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiros Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Med-Polonia

Poznan, , Poland

Site Status

Countries

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Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CRE 027

Identifier Type: -

Identifier Source: org_study_id