Anatomical Shoulder™ Inverse/Reverse Study

Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study

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

Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:

• Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.

Study Overview

• Status: Completed
• Conditions: Cuff-tear Arthropathy
• Intervention / Treatment: Procedure: Inverse/Reverse Shoulder Arthroplasty

Detailed Description

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

All patients will undergo pre-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 either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge.

There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • AZ Monica Antwerpen
• Germany
  • Hamburg, Germany
    • HELIOS ENDO-Klinik Hamburg
  • Kassel, Germany
    • Vitos Orthopädische Klinik Kassel
• Switzerland
  • Zürich, Switzerland
    • Uniklinik Balgrist
• United Kingdom
  • Manchester, United Kingdom
    • The Pennine Acute Hospital NHS Trust

Participation Criteria

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 disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty.
• The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal).

Exclusion Criteria:

• Patient is skeletally immature.
• Patient is pregnant.
• Patient is unwilling or unable to cooperate in a follow-up program.
• Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection
• Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inverse / Reverse Shoulder; Patient treated with a inverse / reverse shoulder device.	Procedure: Inverse/Reverse Shoulder Arthroplasty; Implantation of the Anatomical Shoulder Inverse/Reverse System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Performance	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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival (Kaplan-Meier)	The Kaplan-Meier estimator is a non-parametric statistic used to estimate the survival function from lifetime data. It is used to measure the fraction of patients living (in this case without a revision surgery) for a certain amount of time after treatment. A higher score is a better outcome.	10 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2007
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimated): June 9, 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: Inverse Reverse Shoulder
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Chondrocalcinosis; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: 06-U02