Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000464763
Ethics application status
Approved
Date submitted
24/03/2013
Date registered
24/04/2013
Date last updated
24/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
ASR Hip Resurfacing, Chrome and Cobalt Levels and Effect on Vision
Scientific title
Do patients with an ASR hip replacement have elevated blood chrome and cobalt levels and does this cause visual disturbances when compared to the normal population
Secondary ID [1] 282169 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed Hip Replacement 288632 0
Cobalt and Chrome Toxicity 288633 0
Visual Disturbances 288634 0
Condition category
Condition code
Musculoskeletal 288970 288970 0 0
Other muscular and skeletal disorders
Blood 288971 288971 0 0
Other blood disorders
Eye 288973 288973 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Visual acuity in patients with the ASR Hip Replacements
Single assessment made; duration of observation 4hour session
Intervention code [1] 286742 0
Not applicable
Comparator / control treatment
The control group will be a healthy cohort of patients who have not had the ASR prosthesis implanted
Control group
Active

Outcomes
Primary outcome [1] 289143 0
Visual Disturbance recorded via visual electrophysiology
Timepoint [1] 289143 0
Single time point in each participant. Any time after prosthesis insertion, assuming the primary joint remains in situ (i.e. not revised)
Secondary outcome [1] 301922 0
Serum assay of Chrome and Cobalt levels
Timepoint [1] 301922 0
Single time point in each participant. Any time after prosthesis insertion, assuming the primary joint remains in situ (i.e. not revised)

Eligibility
Key inclusion criteria
ASR Hip Replacement
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known visual problems

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Patients will undertake visual electrophysiology to identify if a significant difference (using a P Value <0.05) exists with patients who have an ASR Hip replacement and visual disturbances compared to the population without an ASR Hip replacement

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
1/11/2012
Date of last participant enrolment
Anticipated
31/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 790 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 6603 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 286941 0
Commercial sector/Industry
Name [1] 286941 0
De Puy
Country [1] 286941 0
United Kingdom
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 285726 0
None
Name [1] 285726 0
NIL
Address [1] 285726 0
NIL
Country [1] 285726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288993 0
Sir Charles Gairdner Hospital Group Human Research Ethics Committee
Ethics committee address [1] 288993 0
Hospital Ave Nedlands Western Australia 6009
Ethics committee country [1] 288993 0
Australia
Date submitted for ethics approval [1] 288993 0
Approval date [1] 288993 0
Ethics approval number [1] 288993 0

Summary
Brief summary
The study aims to measure blood levels of Chrome and Cobalt in patients with an ASR Hip replacement in situ and to see if these patients have visual disturbances
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38542 0
A/Prof Riaz Khan
Address 38542 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009
Country 38542 0
Australia
Phone 38542 0
+618 9346 3333
Fax 38542 0
Email 38542 0
[email protected]
Contact person for public queries
Name 38543 0
Dr Timothy Unsworth-smith
Address 38543 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009
Country 38543 0
Australia
Phone 38543 0
+618 9346 3333
Fax 38543 0
Email 38543 0
[email protected]
Contact person for scientific queries
Name 38544 0
Dr Timothy Unsworth-smith
Address 38544 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009
Country 38544 0
Australia
Phone 38544 0
+618 9346 3333
Fax 38544 0
Email 38544 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.