Anatomical Shoulder™ Fracture PMCF Study

NCT ID: NCT02465398

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-05
• Study Completion Date: 2024-03-11

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.

Conditions

Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fracture device

Patient were treated with an Anatomical Shoulder Fracture device.

Group Type: OTHER

Fracture Shoulder Arthroplasty

Intervention Type: PROCEDURE

Implantation of the Anatomical Shoulder Fracture System

Interventions

Fracture Shoulder Arthroplasty

Implantation of the Anatomical Shoulder Fracture System

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliott Goff, PhD

Role: STUDY_CHAIR

Zimmer Biomet, Jr. Clinical Project Lead

Locations

Klinikum Augsburg

Augsburg, , Germany

Uniklinik Balgrist

Zurich, , Switzerland

The Pennine Acute Hospital NHS Trust

Manchester, , United Kingdom

Countries

Germany; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

06-U03

Identifier Type: -

Identifier Source: org_study_id