Osteochondritis Dissecans of Knee Prospective Cohort

Osteochondritis Dissecans Clinical Trial

Official title:

ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02771496
• Other study ID #: 820147
• Status: Active, not recruiting
• Start date: May 2014
• Est. completion date: December 2064

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2064
• Est. primary completion date: May 2064
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans

Intervention

Other:
• Other: observational only- no intervention
Other: observational only- no intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (24)

Lead Sponsor

Collaborator

University of Pennsylvania

Altona Children's Hospital, Boston Children's Hospital, Children's Health Andrews Institute for Orthopaedics & Sports Medicine, Children's Healthcare of Atlanta, Children's Hospital and Health System Foundation, Wisconsin, Children's Hospital Colorado, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Mercy Hospital Kansas City, Connecticut Children's Medical Center, Göteborg University, 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 Hospital for Sick Children, The Rocky Mountain Hospital for Children, University of Minnesota/TRIA Orthopaedic Center, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IKDC questionnaire	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
Primary	PEDI-IKDC questionnaire	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	KOOS Knee score	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
Secondary	Marx Activity Score questionnaire	Measure of physical activity at healthiest and most active state from time of taking to year prior.	baseline up to 50 years
Secondary	Pedi-FABS Score	An eight-item scale that measures level of physical activity and fitness.	baseline up to 50 years
Secondary	Radiographic Healing	Visualization of bone healing through x-ray images.	baseline up to 50 years