NCT02163343

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

June 6, 2014

Last Update Submit

October 30, 2019

Conditions

Fractured Neck of Femur

Keywords

Serum metal ion levelsCathcart/Corail hemiarthroplastyHip replacement

Outcome Measures

Primary Outcomes (1)

  • Change in serum metal ion level (Chromium and Cobalt) at year 2

    One and two years post surgery

Secondary Outcomes (1)

  • The association between Oxford Hip Score, head diameter and metal ion levels.

    up to two years post surgery

Study Arms (1)

No treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 patients receiving a Cathcart Hemiarthroplasty for intracapsular fractured neck of femur at the Royal Berkshire Hospital

You may qualify if:

  • All patients who received a Cathcart Hemiarthroplasty and are able to attend for blood testing and complete a questionnaire (Oxford Hip Score).

You may not qualify if:

  • Those patients too frail or who now live too far away to attend for blood testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG15AN, United Kingdom

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Antonio Andrade, FRCS MSc

    Royal Berkshire NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 13, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2018

Study Completion

December 1, 2019

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations

GB(1)