Osteochondritis Dissecans of Knee Prospective Cohort
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|ClinicalTrials.gov Identifier: NCT02771496|
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment|
|Osteochondritis Dissecans||Other: Other: observational only- no intervention|
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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2064|
|Estimated Study Completion Date :||December 2064|
Patients with OCD
Patients with diagnosis of OCD as confirmed by x-ray or MRI. Surveys collected from patients at 2 years, 5 years, 10 years, and 25 years.
Other: Other: observational only- no intervention
Other: observational only- no intervention
- IKDC questionnaire [ 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.
- PEDI-IKDC questionnaire [ 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.
- KOOS Knee score [ 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.
- Marx Activity Score questionnaire [ Time Frame: baseline up to 50 years ]Measure of physical activity at healthiest and most active state from time of taking to year prior.
- Pedi-FABS Score [ Time Frame: baseline up to 50 years ]An eight-item scale that measures level of physical activity and fitness.
- Radiographic Healing [ Time Frame: baseline up to 50 years ]Visualization of bone healing through x-ray images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771496
|Contact: Shawn Simmons, BAemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Shawn M Simmons, BA 757-719-1831 firstname.lastname@example.org|
|Principal Investigator: James L Carey, MD|
|Principal Investigator:||James L Carey, MD||University of Pennsylvania|