Anatomical Shoulder™ Fracture PMCF Study

Fracture Clinical Trial

Official title:

Anatomical Shoulder™ Fracture Post-Market Surveillance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465398
• Other study ID #: 06-U03
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Shoulder Fractures

Intervention

Procedure:
• Fracture Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Fracture System

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Switzerland	Uniklinik Balgrist	Zürich
United Kingdom	The Pennine Acute Hospital NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Performance	Constant & Murley Score	5 years
Secondary	Survival	Kaplan-Meier	5 and 10 years