The Evaluation of the METS™ Proximal Humeral System

Complications; Arthroplasty Clinical Trial

Official title:

Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774174
• Other study ID #: 16-02
• Status: Completed
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a single centre, non-randomised, post market clinical follow up examining retrospective patient data from a series of surgical cases; which involved the endoprosthetic replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular Endoprosthetic Tumour System) Proximal Humeral system.

The objective of this study is to evaluate the retrospective patient data where patients have been followed up for at least 12 months post operation; to demonstrate the safety of the METS Proximal Humeral replacement system.

Description:

The METS™ Proximal Humeral system is an endoprosthetic replacement designed to restore the length and the function of an arm after the resection of a significant amount of bone tissue; due to a malignant tumour in the proximal humerus. This Post Market Clinical Follow up (PMCF) study is designed to further support the existing evidence that the system is safe and performs as expected, when analysing retrospective patient data that have had a METS™ Proximal Humeral replacement. The target population is male or female subjects aged between 18 years and over who have been implanted with a METS™ Proximal Humeral system at the Royal National Orthopaedic Hospital, Stanmore; and the patient has been followed up for at least 12 months following implantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient aged 18 and over who has been implanted with a METS™ Proximal Humeral system implant at the Royal National Orthopaedic Hospital, Stanmore.

2. Patient has been followed up for at least 12 months following implant surgery

3. Patient had their surgery on or after January 2007

Exclusion Criteria:

1. Patient is currently or has been involved in pending litigation or worker's compensation

2. Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days

Related Conditions & MeSH terms

• Complications; Arthroplasty

Locations

Country	Name	City	State
United Kingdom	Royal National Orthopaedic Hospital	Stanmore

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation of adverse events that occurred within 12 months post implantation	Adverse events within the first 12 months will be assessed and evaluated	Follow Up of 12 months