The Evaluation of the METS™ Proximal Humeral System

NCT02774174 | Completed

• 1 other identifier: 16-02
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Arthroplasty

Keywords

Proximal Humerus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

METS Proximal Humeral system

Implanted with METS Proximal Humerus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient aged 18 and over who has been implanted with a METS™ Proximal Humeral system implant at the Royal National Orthopaedic Hospital, Stanmore.
• Patient has been followed up for at least 12 months following implant surgery
• Patient had their surgery on or after January 2007

You may not qualify if:

• Patient is currently or has been involved in pending litigation or worker's compensation
• Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Study Officials

• William JS Aston, MBBSMRCSFRCS

  Royal National Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)