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

NCT05358574 | Recruiting

• 1 other identifier: MDRG2017-89MS-130E
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Revision of a Shoulder Prosthesis

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Safety; Clinical Benefits

Outcome Measures

Primary Outcomes (1)

• Incidence and frequency of revisions [Product safety based on implant survivorship]

  Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.

  From operation to study completion, 1-10 years

Secondary Outcomes (4)

• Constant and Murley Score

  From post-operative to final follow-up visit, 1-10 years

• Oxford Shoulder Score

  From post-operative to final follow-up visit, 1-10 years

• EuroQol Five Dimensions Questionnaire

  From post-operative to final follow-up visit, 1-10 years

• X-rays

  From post-operative to final follow-up visit, 1-10 years

Study Arms (1)

Patients who received the Anatomical Shoulder Bipolar

Patients who received the Anatomical Shoulder Bipolar and were operated according to the product's IFU and surgical technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder Bipolar System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• The Anatomical Should Bipolar Adaptor is indicated 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
• Patient should have received the Anatomical Shoulder Bipolar System
• Patient should have signed the Informed Consent Form
• Patient is 18-100 years of age, inclusive
• Patient is skeletally mature

You may not qualify if:

• Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
• Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them
• Patient is known to be pregnant or breastfeeding
• Musculoskeletal situation that enables the application of a regular hemi or total shoulder system
• Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible
• Patient's physical conditions that would impair achieving adequate implant support, and/or prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone).
• Signs of infection
• Non-functional deltoid muscle
• Charcot's shoulder (neuroarthropathy)
• Presence of significant injury to the upper brachial plexus
• Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Helios ENDO-Klinik

Hamburg, 22767, Germany

RECRUITING

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Julie Nicoux

CONTACT

+330672613502; julie.nicoux@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 3, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): July 16, 2033
• Study Completion (Estimated): July 16, 2033
• Last Updated: November 25, 2025

Record last verified: 2025-10

Locations

DE (1)