Anatomical Shoulder™ Fracture PMCF Study

Study Overview
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Brief Summary
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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 Oxford Shoulder Score EQ-5D (EuroQol)

Detailed Description
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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.

Official Title
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Anatomical Shoulder™ Fracture Post-Market Surveillance Study

Conditions
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Fracture

Intervention / Treatment
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* Procedure: Fracture Shoulder Arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Performance | Constant & Murley Score | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-center, Fracture shoulder arthroplasty, Three or four part fracture, Hemiarthroplasty, Europe, Non-controlled, Anatomical reconstruction, Proximal