NCT02774174|Completed
The Evaluation of the METS™ Proximal Humeral System
Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective Data
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Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective Data
Sponsor study identifier
observational
51
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 12, 2016
Actual (reported)May 17, 2016
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)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
Implanted with METS Proximal Humerus
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
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP, United Kingdom
William JS Aston, MBBSMRCSFRCS
Royal National Orthopaedic Hospital
51 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2016
First Posted
May 17, 2016
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Correlation of Spinopelvic Parameters and Acetabular Cup Orientation
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
October 22, 2018
Record last verified: 2018-10
This is a retrospective safety evaluation study. Data will already be deidentified before the clinical research team receive it.
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Source: ClinicalTrials.gov.
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