Fractured Neck of Femur Clinical Trial
Official title:
Serum Metal Ion Levels in Patients Who Underwent Cathcart/Corail Hemiarthroplasty for Fractured Neck of Femur
NCT number | NCT02163343 |
Other study ID # | 14/WS/0060 |
Secondary ID | |
Status | Suspended |
Phase | |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | December 2019 |
Verified date | October 2019 |
Source | Royal Berkshire NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Elevated serum metal ions are well recognized in metal-on-metal articulations in total hip replacements. The objective of the study is to see if the Cathcart / Corail device implanted during a hemiarthroplasty (replacement of one half of the hip joint) results in elevated serum metal ion levels (cobalt & chromium) and to see if there is an association between size of Cathcart head used and metal ion levels.
Status | Suspended |
Enrollment | 56 |
Est. completion date | December 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients who received a Cathcart Hemiarthroplasty and are able to attend for blood testing and complete a questionnaire (Oxford Hip Score). Exclusion Criteria: - Those patients too frail or who now live too far away to attend for blood testing. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Berkshire NHS Foundation Trust | Reading | Berkshire |
Lead Sponsor | Collaborator |
---|---|
Royal Berkshire NHS Foundation Trust | DePuy International |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum metal ion level (Chromium and Cobalt) at year 2 | One and two years post surgery | ||
Secondary | The association between Oxford Hip Score, head diameter and metal ion levels. | Whether there is an association between i) Oxford Hip Score at one year, and, ii) head diameter and metal ion levels and year one and year two. | up to two years post surgery |
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