PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband

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Description

The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair.

The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant & Murley and EQ-5D-5L) at 1 year post-operative.

The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

Study Overview

Start Date
June 17, 2022
Completion Date
September 1, 2024
Enrollment
109
Date Posted
January 19, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Ortheo
Saint-Étienne 42100, France

Centre Clinical
Soyaux 16800, France

Eligibility

Study Population
Subjects treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair, according to the IFU and who meet all of the inclusion and none of exclusion criteria.
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
Older than 18 years and skeletally mature;
Willing and able to comply with the study procedures;
Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

Presence of infection;
Insufficient or immature bone;
Insufficient blood supply or previous infections which may hinder the healing process;
Foreign body sensitivity;
Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
The subject is unwilling or unable to give consent or to comply with the follow-up program;
Subject meets any contraindications of the appropriate Instruction for Use.

Study Contact Info

Study Contact Name
Julie Nicoux
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The Quattro® X Suture Anchor with BroadBand™ Tape is intended for use in rotator cuff repairs. It is intended for for the reattachment of soft tissue to bone.

Up to three sites will be involved in this study. The aim is to include a total of 109 consecutive series cases who received the Quattro® X Suture Anchor with BroadBand™ Tape. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
NCTid (if applicable)
NCT05690776