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Recruiting NCT02771496

Osteochondritis Dissecans of Knee Prospective Cohort

Observational Osteochondritis Dissecans

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗