Anatomical Shoulder™ Fracture PMCF Study

NCT02465398 | Completed Results

• 1 other identifier: 06-U03
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 3

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

Conditions

Fracture

Keywords

Fracture shoulder arthroplasty; Three or four part fracture; Hemiarthroplasty; Multi-center; Europe; Non-controlled; Anatomical reconstruction; Proximal

Outcome Measures

Primary Outcomes (1)

• Functional Performance

  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.

  5 years

Study Arms (1)

Fracture device

OTHER

Patient were treated with an Anatomical Shoulder Fracture device.

Procedure: Fracture Shoulder Arthroplasty

Interventions

Fracture Shoulder Arthroplasty PROCEDURE

Implantation of the Anatomical Shoulder Fracture System

Fracture device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Uniklinik Balgrist

Zurich, 8008, Switzerland

Location

The Pennine Acute Hospital NHS Trust

Manchester, M8 5RB, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Elliott Goff
• Organization: Zimmer Biomet

elliott.goff@zimmerbiomet.com

+41 79 222 23 08

Study Officials

• Elliott Goff, PhD

  Zimmer Biomet, Jr. Clinical Project Lead

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 8, 2015
• Study Start: July 5, 2007
• Primary Completion: March 29, 2017
• Study Completion: March 11, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-02

Locations

CH (1); GB (1); DE (1)