Osteochondritis Dissecans of Knee Prospective Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Other: observational only- no intervention.
- Who it may be relevant to
- Registry conditions: Osteochondritis Dissecans. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee
Overview
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 description
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.
Interventions
- Other Other: observational only- no intervention
Other: observational only- no intervention
Primary outcome measures
- IKDC questionnaire [Time frame: baseline up to 50 years]
- PEDI-IKDC questionnaire [Time frame: baseline up to 50 years]
Secondary outcome measures (4)
- KOOS Knee score [Time frame: baseline up to 50 years]
- Marx Activity Score questionnaire [Time frame: baseline up to 50 years]
- Pedi-FABS Score [Time frame: baseline up to 50 years]
- Radiographic Healing [Time frame: baseline up to 50 years]
Eligibility criteria
Inclusion criteria
- Diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or MRI
Exclusion criteria
- Non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Publications
- ROCK Group; Nissen CW, Albright JC, Anderson CN, Busch MT, Carey JL, Carlson C, Carsen S, Chambers HG, Crepeau A, Edmonds EW, Ellermann JM, Ellis HB Jr, Erickson JB, Fabricant PD, Godin J, Ganley TJ, Green DW, Grimm NL, Heyworth BE, Hui Hoi Po J, Kocher MS, Koehler R, Krych AJ, Latz KH, Loveland DM, Lyon RM, Meenen NM, Milewski MD, Myer GD, Nelson BJ, Nepple JJ, Nguyen JC, Pace JL, Paterno MV, Pen PMID 41981903
Identifiers
NCT: NCT02771496 · 820147