Anatomical Shoulder™ Fracture PMCF Study

May 27, 2025 updated by: Zimmer Biomet

Anatomical Shoulder™ Fracture Post-Market Surveillance Study

The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.

Outcome data will be collected using the following standard scoring systems:

- Constant and Murley Score

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
  • Switzerland
      • Zürich, Switzerland, 8008
        • Uniklinik Balgrist
  • United Kingdom
      • Manchester, United Kingdom, M8 5RB
        • The Pennine Acute Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age - 18 years minimum.
  • Sex - male and female.
  • General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
  • Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
  • Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.

Exclusion Criteria:

  • Patient is skeletally immature.
  • Patient is pregnant.
  • Patient is unwilling or unable to cooperate in a follow-up program.
  • Patient is planned for a bilateral shoulder replacement.

  • Patient shows one or more of the following medical conditions:

    • Pathological Fracture
    • Active Infection

  • Patient requires one or more of the following medical interventions:

    • Revision surgery (non-union)
    • Inverse fracture prosthesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fracture device
Patient were treated with an Anatomical Shoulder Fracture device.
Procedure: Fracture Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Fracture System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Performance
Time Frame: 5 years
Constant & Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 and 10 years
Kaplan-Meier
5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Chair: Elliott Goff, PhD, Zimmer Biomet, Jr. Clinical Project Lead

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2007

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimated)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-U03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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