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Trial record 1 of 1 for:    NCT02771496
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Osteochondritis Dissecans of Knee Prospective Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771496
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
Altona Children's Hospital
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Children's Health Andrews Institute for Orthopaedics & Sports Medicine
Children's Healthcare of Atlanta
Children's Hospital Colorado
Children's Hospital of Philadelphia
Children's Hospital and Health System Foundation, Wisconsin
Children's Mercy Hospital Kansas City
Connecticut Children's Medical Center
Hospital for Special Surgery, New York
Kaiser Permanente
Mayo Clinic
National University Hospital, Singapore
Rady Children's Hospital, San Diego
Stanford University
Tennessee Orthopedic Alliance
Texas Scottish Rite Hospital for Children
The Rocky Mountain Hospital for Children
The Hospital for Sick Children
Göteborg University
University of Minnesota/TRIA Orthopaedic Center
Washington University School of Medicine
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment
Osteochondritis Dissecans Other: Other: observational only- no intervention

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 Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Other: Other: observational only- no intervention
Other: observational only- no intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Pedi-FABS Score [ Time Frame: baseline up to 50 years ]
    An eight-item scale that measures level of physical activity and fitness.

  4. Radiographic Healing [ Time Frame: baseline up to 50 years ]
    Visualization of bone healing through x-ray images.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of all ages with osteochondritis dissecans (OCD) or focal articular cartilage defects confirmed via MRI or x-ray.
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Altona Children's Hospital
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Children's Health Andrews Institute for Orthopaedics & Sports Medicine
Children's Healthcare of Atlanta
Children's Hospital Colorado
Children's Hospital of Philadelphia
Children's Hospital and Health System Foundation, Wisconsin
Children's Mercy Hospital Kansas City
Connecticut Children's Medical Center
Hospital for Special Surgery, New York
Kaiser Permanente
Mayo Clinic
National University Hospital, Singapore
Rady Children's Hospital, San Diego
Stanford University
Tennessee Orthopedic Alliance
Texas Scottish Rite Hospital for Children
The Rocky Mountain Hospital for Children
The Hospital for Sick Children
Göteborg University
University of Minnesota/TRIA Orthopaedic Center
Washington University School of Medicine
Investigators
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Principal Investigator: James L Carey, MD University of Pennsylvania
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02771496    
Other Study ID Numbers: 820147
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Bone Diseases
 Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases