Anatomical Shoulder™ Fracture PMCF Study

Zimmer Biomet52 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fracture

Interventions

Fracture Shoulder ArthroplastyPROCEDURE

Implantation of the Anatomical Shoulder Fracture 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 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

Locations (3)

Klinikum Augsburg

Augsburg, Germany

Uniklinik Balgrist

Zurich, Switzerland

The Pennine Acute Hospital NHS Trust

Manchester, United Kingdom

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: 5 years

Data from ClinicalTrials.gov

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