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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02774174
Other study ID # 16-02
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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