Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000171617
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
18/08/2005
Date last updated
6/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study of the effects of weight loss on knee pain, function and appearance on x-ray in severely obese women.
Scientific title
A prospective study of the effects of weight loss on knee pain, function and appearance on x-ray in severely obese women.
Secondary ID [1] 253242 0
knee pain and weight loss
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee pain 266 0
Condition category
Condition code
Diet and Nutrition 299 299 0 0
Obesity
Musculoskeletal 300 300 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
100 consecutive consenting severely obese women with knee pain who are presenting for weight loss surgery with the Lap-Band will have their knee symptoms clinically assessed in both knees, a standard set of x-rays of both knees taken and will answer the WOMAC questionnaire (a validated knee symptom and disability instrument) as well as a questionnaire designed to gather individual assessment of weight history, past knee injury and injury management, and activity and sporting volume history. The set of assessments will be repeated at 2-years.
Intervention code [1] 199 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 352 0
Change in knee symptoms
Timepoint [1] 352 0
At 2 years
Secondary outcome [1] 793 0
Radiological changes in knees. Elucidation of factors that predict a greater prevalence of knee symptoms, dysfunction and degenerative arthritis in severely obese women presenting for Lap-Band surgery, assessment of any relationship with degree of weight loss and change in knee symptoms.
Timepoint [1] 793 0
At 2-years.

Eligibility
Key inclusion criteria
Body mass index greater than 35kg/m2, with a problem or symptom related to at least one knee joint and can give informed consent to participation in the study.
Minimum age
20 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of a known non-degenerative arthritic condition such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis or gout, pregnancy, previous history of knee arthroplasty.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 357 0
University
Name [1] 357 0
Centre for Obesity Research and Education (CORE) Monash University
Country [1] 357 0
Australia
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE) Monash University
Address
Monash University Medical School Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 283 0
None
Name [1] 283 0
none
Address [1] 283 0
Country [1] 283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1330 0
The Avenue Hospital
Ethics committee address [1] 1330 0
Ethics committee country [1] 1330 0
Australia
Date submitted for ethics approval [1] 1330 0
Approval date [1] 1330 0
03/10/2003
Ethics approval number [1] 1330 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35763 0
Address 35763 0
Country 35763 0
Phone 35763 0
Fax 35763 0
Email 35763 0
Contact person for public queries
Name 9388 0
Ms Cheryl Laurie
Address 9388 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9388 0
Australia
Phone 9388 0
+61 3 99030721
Fax 9388 0
+61 3 95103365
Email 9388 0
[email protected]
Contact person for scientific queries
Name 316 0
Associate Professor John Dixon
Address 316 0
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country 316 0
Australia
Phone 316 0
+61 3 9902 4511
Fax 316 0
+61 3 8575 2233
Email 316 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.