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

Rotator Cuff Tears Clinical Trial

Official title:
Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05690776
Study type Observational
Source Zimmer Biomet
Contact Julie Nicoux
Phone 0672613502
Email julie.nicoux@zimmerbiomet.com
Status Recruiting
Phase
Start date June 17, 2022
Completion date September 1, 2024
View Details
See also
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