Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12612000566831
Ethics application status
Not yet submitted
Date submitted
25/05/2012
Date registered
25/05/2012
Date last updated
25/05/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Determining how common damage to the hip cartilage occurs without causing symptoms
Query!
Scientific title
Defining the prevalence of acetabular labral tears in young asymptomatic using magnetic resonance imaging
Query!
Secondary ID [1]
280555
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hip acetabular labral tears
286553
0
Query!
Condition category
Condition code
Musculoskeletal
286821
286821
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Healthy volunteers who have no hip pain will undergo one magnetic resonance imaging (MRI), to see the prevalence of asymptomatic hip acetabular labral tears. Each MRI scan will take approximately 20 minutes.
Query!
Intervention code [1]
284944
0
Not applicable
Query!
Comparator / control treatment
Since this study is essentially a prevalence study, there is no control group.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
287187
0
Identifying incidence of hip acetabular labral tears using magnetic resonance imaging
Query!
Assessment method [1]
287187
0
Query!
Timepoint [1]
287187
0
Within one year of selecting volunteers. (volunteers will get their magnetic resonance imaging at various times throughout the year)
Query!
Secondary outcome [1]
297578
0
Incidence of hip pain in those volunteers where acetabular labral tear was identified. This will be done using a modified Harris Hip Score that is to be incooporated into a standardized questionnaire.
Query!
Assessment method [1]
297578
0
Query!
Timepoint [1]
297578
0
Participants with labral tears will be contacted yearly. We anticipate we will produce a summary of the obtained results in a follow up study at 5 and 10 years after the magnetic resonance imaging was performed
Query!
Secondary outcome [2]
297589
0
This is in regards to those participants who have labral tears, and develops symptoms from it. We will study if there are any associations between developing a symptomatic labral tear and any of the demographic details (obtained prior to the MRI scanning). The demographic details are weight, ethnicity, smoking habit, amount and duration of regular sports/recreational activities
Query!
Assessment method [2]
297589
0
Query!
Timepoint [2]
297589
0
This subset of participants will be followed up yearly as explained in 'secondary outcome 1'. When all data are available, we will be performing statistical calculations for our follow up studies to see if there are any significant associations. This will occur at 5 and 10 years after the MRI scan.
Query!
Eligibility
Key inclusion criteria
Healthy volunteers without any previous hip problems and aged between 20 and 45 years of age.
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Previous history of hip problems, hip pain, treatment of any kind to the hip, history of inflammatory joint/connective tissue disease. Participants who have contradindications to magnetic resonance imaging (eg. claustrophobia, pregnancy, metal foreign bodies)
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/07/2012
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
4333
0
New Zealand
Query!
State/province [1]
4333
0
Query!
Funding & Sponsors
Funding source category [1]
285318
0
Charities/Societies/Foundations
Query!
Name [1]
285318
0
New Zealand Orthopaedic Association
Query!
Address [1]
285318
0
Level 12
Greenock House
39 The Terrace
Wellington 6011
Query!
Country [1]
285318
0
New Zealand
Query!
Primary sponsor type
Hospital
Query!
Name
Christchurch Hospital
Query!
Address
Ricarton Avenue
Private Bag 4710
Christchurch
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
284175
0
Commercial sector/Industry
Query!
Name [1]
284175
0
Christchurch Radiology Group
Query!
Address [1]
284175
0
137 Leinster Road
Merivale
Christchurch 8014
Query!
Country [1]
284175
0
New Zealand
Query!
Ethics approval
Ethics application status
Not yet submitted
Query!
Ethics committee name [1]
287337
0
Health and Disability Ethics Committees - Upper South A regional ethics committee
Query!
Ethics committee address [1]
287337
0
c/- Ministry of Health 6 Hazeldean Road Sydenham Christchurch 8023
Query!
Ethics committee country [1]
287337
0
New Zealand
Query!
Date submitted for ethics approval [1]
287337
0
26/01/2012
Query!
Approval date [1]
287337
0
Query!
Ethics approval number [1]
287337
0
Query!
Summary
Brief summary
Acetabular labrum is a ring of fibrous cartilage around the hip joint, which helps the stability of the hip joint and evenly distribute forces put upon the hip joint. Disease of this labrum may cause hip pain in the young population, and may lead to development of early osteoarthritis. Because this is a relatively new entity, not much is known about its prevalence and natural history. Few studies have shown that significant proportion of asymptomatic population may have an acetabular labral tears. We intend to define the prevalence of acetabular labral tears in the asymptomatic population. Furthermore, where labral tear was identified, we plan to follow up those participants yearly, to monitor if the participants develop hip pain. We will then attempt to identify any predisposing factors (such as exercise levels, smoking habits) which may make some participants more prone to developing symptoms. These participants will be followed up every year, and summary of the findings will be produced at 5 and 10 years since the magnetic resonance imaging was performed.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
34224
0
Query!
Address
34224
0
Query!
Country
34224
0
Query!
Phone
34224
0
Query!
Fax
34224
0
Query!
Email
34224
0
Query!
Contact person for public queries
Name
17471
0
Alex Lee
Query!
Address
17471
0
154 Stanmore Road
Linwood
Christchurch 8011
Query!
Country
17471
0
New Zealand
Query!
Phone
17471
0
+64 21 0745314
Query!
Fax
17471
0
Query!
Email
17471
0
[email protected]
Query!
Contact person for scientific queries
Name
8399
0
Alex Lee
Query!
Address
8399
0
154 Stanmore Road
Linwood
Christchurch 8011
Query!
Country
8399
0
New Zealand
Query!
Phone
8399
0
+64 21 0745314
Query!
Fax
8399
0
Query!
Email
8399
0
[email protected]
Query!
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.
Download to PDF