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临床试验/NCT02771496
NCT02771496招募中不适用

ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
2
主要终点
PEDI-IKDC questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or MRI

排除标准

  • Non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)

结局指标

主要结局

PEDI-IKDC questionnaire

时间窗: 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.

IKDC questionnaire

时间窗: 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.

次要结局

  • Radiographic Healing(baseline up to 50 years)
  • Pedi-FABS Score(baseline up to 50 years)
  • KOOS Knee score(baseline up to 50 years)
  • Marx Activity Score questionnaire(baseline up to 50 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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