NCT02465398

Anatomical Shoulder™ Fracture PMCF Study

Anatomical Shoulder™ Fracture Post-Market Surveillance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture

Interventions

Type	Name	Description
PROCEDURE	Fracture Shoulder Arthroplasty	Implantation of the Anatomical Shoulder Fracture System

Timeline

• Start date: 2007-07-05
• Primary completion: 2017-03-29
• Completion: 2024-03-11
• First posted: 2015-06-08
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

3 sites across 3 countries: Germany, Switzerland, United Kingdom