- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02771496
Osteochondritis Dissecans of Knee Prospective Cohort
ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Other: observational only- no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline up to 50 years
|
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.
|
baseline up to 50 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline up to 50 years
|
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.
|
baseline up to 50 years
|
Pedi-FABS Score
Time Frame: baseline up to 50 years
|
An eight-item scale that measures level of physical activity and fitness.
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baseline up to 50 years
|
Radiographic Healing
Time Frame: baseline up to 50 years
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Visualization of bone healing through x-ray images.
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baseline up to 50 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James L Carey, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 820147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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