Complications; Arthroplasty Clinical Trial
Official title:
Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective 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 |
Verified date | October 2018 |
Source | Stryker Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal National Orthopaedic Hospital | Stanmore |
Lead Sponsor | Collaborator |
---|---|
Stryker Orthopaedics |
United Kingdom,
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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