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Serum Metal Ion Levels in Patients Who Underwent Cathcart/Corail Hemiarthroplasty for Fractured Neck of Femur

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163343
Recruitment Status : Suspended
First Posted : June 13, 2014
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Royal Berkshire NHS Foundation Trust

Brief Summary:
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.

Condition or disease
Fractured Neck of Femur

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Serum Metal Ion Levels in Patients Who Underwent Cathcart/Corail Hemiarthroplasty for Fractured Neck of Femur
Actual Study Start Date : June 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
No treatment



Primary Outcome Measures :
  1. Change in serum metal ion level (Chromium and Cobalt) at year 2 [ Time Frame: One and two years post surgery ]

Secondary Outcome Measures :
  1. The association between Oxford Hip Score, head diameter and metal ion levels. [ Time Frame: up to two years post surgery ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 patients receiving a Cathcart Hemiarthroplasty for intracapsular fractured neck of femur at the Royal Berkshire Hospital
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163343


Locations
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United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom, RG15AN
Sponsors and Collaborators
Royal Berkshire NHS Foundation Trust
DePuy International
Investigators
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Principal Investigator: Antonio Andrade, FRCS MSc Royal Berkshire NHS Foundation Trust
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Responsible Party: Royal Berkshire NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02163343    
Other Study ID Numbers: 14/WS/0060
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Keywords provided by Royal Berkshire NHS Foundation Trust:
Serum metal ion levels
Cathcart/Corail hemiarthroplasty
Hip replacement
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries