Anatomical Shoulder™ Inverse/Reverse Study

Zimmer, GmbH154 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Cuff-tear Arthropathy

Interventions

Inverse/Reverse Shoulder ArthroplastyPROCEDURE

Implantation of the Anatomical Shoulder Inverse/Reverse System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

AZ Monica Antwerpen

Antwerp, Belgium

HELIOS ENDO-Klinik Hamburg

Hamburg, Germany

Vitos Orthopädische Klinik Kassel

Kassel, Germany

Uniklinik Balgrist

Zurich, Switzerland

The Pennine Acute Hospital NHS Trust

Outcomes

Primary Outcomes

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.

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 10 years

Data from ClinicalTrials.gov

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