Anatomical Shoulder™ Fracture PMCF Study

Fracture Clinical Trial

Official title: Anatomical Shoulder™ Fracture Post-Market Surveillance Study

Status Completed

Clinical Trial 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

• Oxford Shoulder Score

• EQ-5D (EuroQol)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Shoulder Fractures

• NCT number: NCT02465398
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Completion date: March 31, 2024