WOMAC Hip Score in Children and Adolescents With Perthes Disease (NCT02795494) | Clinical Trial Compass
UnknownNot Applicable
WOMAC Hip Score in Children and Adolescents With Perthes Disease
Canada200 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range
5 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All participants will be between 5-19 years
* Healed Perthes disease. Healed Perthes disease will be defined radiographically, in the accepted fashion, by the appearance of normal bone density of the femoral head. The restriction of those with Perthes disease to only those with resolution of the disease will prevent heterogeneity of the clinical presentation and anticipated functional abilities which would occur by including those in the acute phases of the disease, thereby reducing potential bias.
* All participants will have to be able to complete the questionnaires in English and, for those with Perthes disease, be able to complete the questionnaires again two weeks following the initial completion.
Exclusion Criteria:
* Amongst those being followed at the orthopaedic clinic of a participating center with an upper extremity fracture, those with a history of a hip disorder will be excluded. The reason for this is that these subjects will compose a comparison group with normal hip function, consequently a history of hip disorder would bias this comparison.
* Those with Perthes disease who demonstrate acute phases of the disease will be excluded. Acute phases of the disease will be defined in the accepted fashion, by the radiographic presence of fragmentation or reossification of the femoral head.
* Those who do not provide consent for participation in the study will be excluded, as will those who either cannot complete the questionnaire in English or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in WOMAC questionnaire scores between the five Stulberg classification stages in the Perthes group