PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet

About this trial

The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Eligibility criteria

Qualifiers

Patients 18 years or older and skeletally mature

Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study

Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment

Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment

Disqualifiers

Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.

The patient is known to be pregnant or breastfeeding

Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.

Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

78 Participants
are grouped into 1 trial group

Sponsors and collaborators