University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT02771496
The Cohort is a multi-site prospective data collection study that will enroll any patient with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be followed for up to the next 50 years of their lives to study courses of care, disease progression, treatment/surgical options/results, and specific sports-related outcomes in athletic patients. Subjects will complete quality of life surveys as part of the Cohort. Course of care will not be affected.
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Observational
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Patients will be recruited and consented at the visit in which their eligibility is determined. Once a patient is eligible and provides informed consent, he or she will be in the study for up to 50 years, or until his or her OCD lesion is healed successfully.
At the initial visit, a subject will complete a basic medical history form, and three questionnaires: the IKDC Subjective questionnaire (ages over 18) or the PEDI-IKDC Subjective questionnaire (ages under 18); the KOOS questionnaire; and the Marx Activity Scale (adult) or Pedi-FABS Scale (pediatric). Patients will then continue with their normal course of care as determined by their surgeon and care team.
Mandatory surveys (same as above) will be collected from patients at 2 years, 5 years, 10 years, and 25 years. Patients who cannot return to clinic will have the option to complete the assessments and return in pre-stamped and addressed return envelopes provided by the clinical site the subject is a patient at. Any other follow-up visits between these time intervals will also be options for patients to complete these assessments, however patients will not complete them any closer than intervals 12 weeks apart in order to prevent redundancy.
Additionally, at the initial visit, the surgeon will complete a routine patient history and physical exam, which will be collected. Any surgical procedures or physical therapy a patient undergoes for treatment of his or her OCD lesion will also be documented and collected. At follow-up visits, surgeons will complete their own physical exam follow-up assessment forms, which will be collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other: observational only- no intervention
Time frame: baseline up to 50 years
The primary outcome endpoint for this study is the patient's score on the IKDC Subjective questionnaire, or PEDI-IKDC Subjective questionnaire for patients under 18 years of age.
Time frame: baseline up to 50 years
The primary outcome endpoint for this study is the patient's score on the IKDC Subjective questionnaire, or PEDI-IKDC Subjective questionnaire for patients under 18 years of age.
Time frame: baseline up to 50 years
The Knee injury and Osteoarthritis Outcome Score (KOOS) evaluates short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis.
Time frame: baseline up to 50 years
Measure of physical activity at healthiest and most active state from time of taking to year prior.
Time frame: baseline up to 50 years
An eight-item scale that measures level of physical activity and fitness.
Time frame: baseline up to 50 years
Visualization of bone healing through x-ray images.
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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