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Clinical Trial

Offered by: 91��Ƭ�����߿� Children's
Location: Delaware Valley

Trial Name

SCFE – (SLIP) Registry – (Slipped Longitudinal International Prospective)

What is the trial about?

Establish an international data registry for SCFE with hospitals around the world contributing data from patients over a long period of time. This study will collect cases from many doctors and hospitals from around the world into one international computer database.

Who can participate?

If your child has been diagnosed with SCFE and is under the age of 18. Your child will have had no known or suspected neuromuscular (nerve and muscle), ligament or tendon, genetic, or lower limb problems present at birth. Parents or guardians must consent to participate in the study and thus must be able to understand and read English or have the aid of a translator. Once your child  turns 19 years old, your will be asked if they wish to continue to participate in this study. If we are unable to reach them for re-consent to the study, their data will remain in the registry and continue to be collected. 

What is involved?

Your child can expect to be part of this research study for the length of their treatment by the orthopaedic department. Your doctor will schedule routine follow-up visits until your child has stopped growing (skeletal maturity). Children typically reach skeletal maturity between the ages of 14 and 18 years. We do not expect each follow-up clinic visit for research purposes to take longer than 5-10 minutes on average. We are aware of the time you are committing to the project, so the research team will do their best to see you after you’ve had your x-rays taken and before you see the doctor. If at some point you do not return for clinical visits, we will attempt to contact you by telephone or mail to obtain your continued consent. If you cannot be contacted, you will be considered lost to follow-up and any previously collected data will be kept for analysis purposes. Whether or not you take part in this study is your choice. You can choose to stop participating for any reason at any time. However, if you decide to stop participating in the study, we encourage you to tell the researchers.

Clinical Information

If you agree to have your child be in this study, you will be asked to sign this consent form. By agreeing to be in the study, you are allowing the research staff to collect information about your child’s treatment progress at each regular clinic visits. Your child will not be required to attend any extra visits to the clinic.

At each regular clinic visit, your child’s clinical data will be collected by the research team. Data from existing records will also be collected including your child’s date of birth (month and year only), age, gender, ethnicity, information about your height/weight, symptoms, diagnosis, clinic visits and dates, tests and treatments, responses to questionnaires, family history and medical history.

Demographic information helps us to identify different characteristics of the SCFE patient population and if the participants included in the study are truly representative of the entire SCFE population for generalization purposes. Once data is public that includes your information, you will not be able to withdraw your data. This information you provide us with is completely voluntary as is your participation in this study.

As part of the study, de-identified x-rays and ultrasound images of your hip will be kept for measurement and analysis purposes. No identifying information will be retained with these images.

At the final follow-up visit, you will be asked to complete a “functional outcomes” questionnaire about physical function and pain and stiffness from your hip. This questionnaire should take no longer than 12 minutes to complete. You are free to only answer questions you are comfortable answering. Your data will continue to be collected until your final clinic visit, decided upon by you and your doctor.

All of your information will be collected and stored via a secure web application, REDCap, indefinitely and will include de-identified radiographic imaging, clinical information and questionnaire responses.