Anatomical Shoulder™ Fracture PMCF Study

Not Applicable

Completed

Brief Summary: 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

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Functional Performance	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Klinikum Augsburg
🇩🇪
Augsburg, Germany
Uniklinik Balgrist
🇨🇭
Zürich, Switzerland
The Pennine Acute Hospital NHS Trust
🇬🇧
Manchester, United Kingdom
Klinikum Augsburg
🇩🇪Augsburg, Germany