Clinical Trial: WOMAC Hip Score in Children and Adolescents With Perthes Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Validation and Reliability Testing of the Western Ontario and McMaster Osteoarthritis Scale (WOMAC) Hip Score in Children and Adolescents With Perthes Disease
Brief Summary:
Patient oriented clinical outcomes have increased in use and popularity and provide a comprehensive assessment of the level of symptoms and function experienced by a patient. Though several measures have been developed and shown to be valid, reliable, and responsive in adults, such efforts have only been rarely undertaken in pediatric populations. Specifically, there has been no validation of the predominant adult hip specific outcome measures, such as the WOMAC and Oxford-12, in children and adolescents. Prior to using such measures in pediatric patients, it is necessary to establish the psychometric properties of these measurements in this population.
The objective of this study is to determine the reliability and validity of the WOMAC hip scores in a pediatric population, between five and nineteen years of age, with Perthes disease. The results of this study will accomplish the above goal, thereby allowing either for widespread use of these measures in pediatric hip disorders or emphasizing the necessity for development of a pediatric hip specific outcome measure.
Detailed Summary:
- Purpose Perthes disease is a hip disorder most often affecting children with an onset between four and eight years of age. The treatment options range from non-operative to bracing to operative intervention. As the disease most often affects the head of the femur, there is the potential for long-term conditions due to the residual hip joint deformity, following resolution of Perthes disease, leading to early degenerative hip osteoarthritis and potential impact on hip function, quality of life, and morbidity. A valid and reliable means by which to assess function and outcome is essential to determine the most effective means of treatment. Previous research has used different methods in different subject groups, making comparisons of results very difficult. Both the long-term outcome and change over time of a patient with Perthes disease could be measured with a hip joint specific patient oriented outcome measure. Several such measures have been developed in adults; specifically the Western Ontario and McMaster Osteoarthritis Scale (WOMAC) hip score are used very often. Though these tools have been well studied and validated in adults, they have not been tested or used in pediatric populations. As they were developed and shown to be valid, reliable, and responsive in adults, these measures require rigourous testing in pediatric populations prior to their use.
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Hypothesis There is no true global hypothesis for the study since it is a validation/reliability study. There are hypotheses for each type of validity being studied.
For construct validity (using convergence), the hypothesis would be a priori hypothesis in this study related to convergent validity is that, assuming the WOMAC has construct validity in this population, then the hip specific outcome scores sho
Sponsor: British Columbia Children's Hospital
Current Primary Outcome: Difference in WOMAC questionnaire scores between the five Stulberg classification stages in the Perthes group [ Time Frame: Baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Difference in WOMAC questionnaire scores between baseline and 2 weeks [ Time Frame: Baseline to two weeks ]
- Difference in WOMAC questionnaire scores between the Perthes and control group [ Time Frame: Baseline ]
- Correlation between WOMAC questionnaire and ASK-P scores in the Perthes group [ Time Frame: Baseline ]
Original Secondary Outcome: Same as current
Information By: British Columbia Children's Hospital
Dates:
Date Received: May 26, 2016
Date Started: May 2007
Date Completion: May 2020
Last Updated: June 6, 2016
Last Verified: June 2016
