Osteochondritis Dissecans of Knee Prospective Cohort

NCT ID: NCT02771496

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2064-12-31

Brief Summary

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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

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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.

Conditions

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Osteochondritis Dissecans

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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: observational only- no intervention

Intervention Type OTHER

Other: observational only- no intervention

Interventions

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Other: observational only- no intervention

Other: observational only- no intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Altona Children's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Children's Health Andrews Institute for Orthopaedics & Sports Medicine

UNKNOWN

Sponsor Role collaborator

Children's Healthcare of Atlanta

OTHER

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Rady Children's Hospital, San Diego

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Tennessee Orthopedic Alliance

OTHER

Sponsor Role collaborator

Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role collaborator

The Rocky Mountain Hospital for Children

UNKNOWN

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

University of Minnesota/TRIA Orthopaedic Center

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James L Carey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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820147

Identifier Type: -

Identifier Source: org_study_id

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