Clinical trial NCT02774174: The Evaluation of the METS™ Proximal Humeral System
Official title: Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications; Arthroplasty
Keywords: Proximal Humerus
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Evaluation of adverse events that occurred within 12 months post implantation
timeFrame: Follow Up of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: Royal National Orthopaedic Hospital
name: William JS Aston, MBBSMRCSFRCS
role: PRINCIPAL_INVESTIGATOR
References: