Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02795494
Eligibility Criteria:
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 are unable to complete a second set of questionnaires at two weeks.
* Those with cognitive impairment, precluding completion of the questionnaires, will be excluded.
* All those with concomitant medical problems will be excluded due to possible confounding of the clinical outcome measures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
19 Years
Study:
NCT02795494
Study Brief:
Protocol Section:
NCT02795494