NCT05358574

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

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a monocentric, 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 Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement. 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 Bipolar System is intended for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible. The system is intended for long-term implantation into the human shoulder joint. One site will be involved in this study. The aim is to include a maximum of 40 consecutive series cases who received the Anatomical Shoulder Bipolar starting from 2009 until 2020. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preop, intraop and immediate post-op intervalls will be available in medical notes and collected retrospectively. During follow-up visits at 1, 2, 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.

Conditions

• Revision of a Shoulder Prosthesis

Timeline

• Start date: 2022-04-22
• Primary completion: 2033-07-16
• Completion: 2033-07-16
• First posted: 2022-05-03
• Last updated: 2025-11-25

Locations

1 site across 1 country: Germany