Clinical Trial: Osteochondritis Dissecans of Knee Prospective Cohort

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: University of Pennsylvania

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: May 10, 2016
Date Started: May 2014
Date Completion: December 2064
Last Updated: May 12, 2016
Last Verified: April 2016