PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
brief summary
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.
detailed description
The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoulder arthroplasty. The system is intended for long-term implantation into the human shoulder joint to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Two sites will be involved in this study. The aim is to include a total of 78 consecutive series cases who received the Anatomical Shoulder 2.0 Fracture starting from 2014. 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, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
official title
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study