Clinical trial NCT02771496: Osteochondritis Dissecans of Knee Prospective Cohort
Official title: ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteochondritis Dissecans
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Altona Children's Hospital
name: Boston Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Children's Health Andrews Institute for Orthopaedics & Sports Medicine
name: Children's Healthcare of Atlanta
name: Children's Hospital Colorado
name: Children's Hospital of Philadelphia
name: Children's Hospital and Health System Foundation, Wisconsin
name: Children's Mercy Hospital Kansas City
name: Connecticut Children's Medical Center
name: Hospital for Special Surgery, New York
name: Kaiser Permanente
name: Mayo Clinic
name: National University Hospital, Singapore
name: Rady Children's Hospital, San Diego
name: Stanford University
name: Tennessee Orthopedic Alliance
name: Texas Scottish Rite Hospital for Children
name: The Rocky Mountain Hospital for Children
name: The Hospital for Sick Children
name: Göteborg University
name: University of Minnesota/TRIA Orthopaedic Center
name: Washington University School of Medicine
First posted: 2016-05-13
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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)

Primary outcomes:
measure: IKDC questionnaire
timeFrame: baseline up to 50 years
measure: PEDI-IKDC questionnaire
timeFrame: baseline up to 50 years
Secondary outcomes:
measure: KOOS Knee score
timeFrame: baseline up to 50 years
measure: Marx Activity Score questionnaire
timeFrame: baseline up to 50 years
measure: Pedi-FABS Score
timeFrame: baseline up to 50 years
measure: Radiographic Healing
timeFrame: baseline up to 50 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James L Carey, MD
role: PRINCIPAL_INVESTIGATOR
References: