Trial Review

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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
Scientific title
Defining the prevalence of acetabular labral tears in young asymptomatic using magnetic resonance imaging
Secondary ID [1] 280555 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip acetabular labral tears 286553 0
Condition category
Condition code
Musculoskeletal 286821 286821 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 284944 0
Not applicable
Comparator / control treatment
Since this study is essentially a prevalence study, there is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287187 0
Identifying incidence of hip acetabular labral tears using magnetic resonance imaging
Timepoint [1] 287187 0
Within one year of selecting volunteers. (volunteers will get their magnetic resonance imaging at various times throughout the year)
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.
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
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
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.

Eligibility
Key inclusion criteria
Healthy volunteers without any previous hip problems and aged between 20 and 45 years of age.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4333 0
New Zealand
State/province [1] 4333 0

Funding & Sponsors
Funding source category [1] 285318 0
Charities/Societies/Foundations
Name [1] 285318 0
New Zealand Orthopaedic Association
Country [1] 285318 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Ricarton Avenue
Private Bag 4710
Christchurch
Country
New Zealand
Secondary sponsor category [1] 284175 0
Commercial sector/Industry
Name [1] 284175 0
Christchurch Radiology Group
Address [1] 284175 0
137 Leinster Road
Merivale
Christchurch 8014
Country [1] 284175 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287337 0
Health and Disability Ethics Committees - Upper South A regional ethics committee
Ethics committee address [1] 287337 0
c/- Ministry of Health
6 Hazeldean Road
Sydenham
Christchurch 8023
Ethics committee country [1] 287337 0
New Zealand
Date submitted for ethics approval [1] 287337 0
26/01/2012
Approval date [1] 287337 0
Ethics approval number [1] 287337 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34224 0
Address 34224 0
Country 34224 0
Phone 34224 0
Fax 34224 0
Email 34224 0
Contact person for public queries
Name 17471 0
Alex Lee
Address 17471 0
154 Stanmore Road
Linwood
Christchurch 8011
Country 17471 0
New Zealand
Phone 17471 0
+64 21 0745314
Fax 17471 0
Email 17471 0
[email protected]
Contact person for scientific queries
Name 8399 0
Alex Lee
Address 8399 0
154 Stanmore Road
Linwood
Christchurch 8011
Country 8399 0
New Zealand
Phone 8399 0
+64 21 0745314
Fax 8399 0
Email 8399 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.