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| ID | Type | Description | Link |
|---|---|---|---|
| Peking University Third Hospit | Other Grant/Funding Number | BYSYDL2025034 |
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This is a non-randomized, observational, ambidirectional cohort study. Approximately 254 participants with knee OCD will be recruited from Peking University Third Hospital, China, comprising a prospective cohort (n=177) and a retrospective cohort (n=77). The study aims to observe and compare the long-term outcomes among patients receiving different standard-of-care treatments. Treatment decisions (conservative management or specific surgical interventions) are made by clinicians and patients according to prevailing clinical guidelines and individual conditions, independent of this study.
Based on the treatment they receive in clinical practice, participants will be categorized into two main exposure groups: the conservative treatment group and the surgical treatment group. The surgical group will be further stratified into six subgroups according to the specific surgical technique employed. All participants will enter a follow-up phase lasting up to 24 months.
Assessments will include the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score (primary outcome), the International Knee Documentation Committee (IKDC) Subjective Knee Form, pain intensity (Visual Analog Scale, VAS), Lysholm knee score, as well as the incidence of complications and Adverse Events (AEs)/Serious Adverse Events (SAEs). For patients undergoing surgery, these measurements will be conducted at the following time points: preoperatively, intraoperatively, and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. For patients under conservative management, follow-up assessments will be conducted at corresponding clinical time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Management Cohort | Patients in this cohort receive non-surgical management, which may include activity restriction, braces/orthoses, immobilizers/casts, therapeutic ultrasound, analgesics, anti-inflammatory medications, and/or Traditional Chinese Medicine (TCM). |
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| Surgical Treatment Cohort | Patients who undergo any of the following standard surgical procedures as part of their routine clinical care: joint debridement, internal fixation, retroarticular drilling, microfracture, autogenous transplantation, or allograft transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Management for OCD (Observed) | Other | This is not an intervention assigned by the study. It encompasses the spectrum of standard conservative and surgical treatments that participants may receive as part of independent clinical care. The specific treatment each participant receives is documented and used to define the study cohorts for observational comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score | In this study, the MOCART scoring system was used to quantitatively assess the quality of postoperative cartilage repair. This scoring was based on postoperative MRI and evaluated comprehensively from 9 dimensions including the integrity of the repaired tissue, surface condition, signal intensity, and integration with surrounding tissues. The total score ranged from 0 to 100. The higher the score, the better the morphological outcome of the cartilage repair. Previous studies have suggested that a score of more than 70 indicates good repair, and a score of more than 85 indicates excellent repair. | preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Tegner Activity Scale | It is a one-dimensional scale ranging from 0 to 10, used to assess the activity level of patients in terms of sports and daily work. The higher the score, the higher the activity level of knee joint. High score (8-10 points): Indicates the level of competitive sports, with extremely high requirements for the knee joint. Medium score (4-7 points): Represents recreational sports and physical labor, which is the level of most active people. Low score (0-3 points): Represents daily life and sedentary work, with a lower load on the knee joint. |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Preoperatively | |
| Weight | Preoperatively | |
| AE/SAE |
Inclusion Criteria:
Exclusion Criteria:
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This study aims to establish a two-way cohort for the treatment of osteochondritis dissecans (OCD) of the knee joint. The target population consists of patients with knee OCD who have been diagnosed through clinical and imaging (MRI) examinations and are treated at the Department of Sports Medicine of Peking University Third Hospital. The age range is from 6 years old to 40 years old (inclusive).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The damaged cartilage and synovial tissues during the surgery may be preserved.
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| preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. |
| International Knee Documentation Committee (IKDC)-2000 | It can comprehensively assess the knee joint's functionality, consisting of 18 questions, covering three dimensions: symptoms, sports activity function, and daily activity function. The higher the score, the better the knee joint's functionality and the fewer the symptoms. Generally, a score of >90 indicates excellent function, while a score of <70 indicates significant functional impairment. The minimum clinically important difference is approximately 10-12 points. | preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. |
| Lysholm Knee Score | It can assess specific symptoms and functional impairments of the knee joint, and has particular advantages in reflecting instability and limitations in daily activities. It consists of 8 items, with a total score of 100. The higher the score, the better the function. Function classification (widely accepted standard): Excellent: 95 - 100 points; Good: 84 - 94 points; Average: 65 - 83 points; Poor: < 65 points. | preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. |
| Visual Analog Scale | It can quantify the intensity of subjective pain and is the simplest and most direct method for pain assessment. It is usually a horizontal line 10 centimeters long, with "no pain" marked at the left end (0 points) and "the most intense pain" marked at the right end (10 points). The patient marks their own sensation on the line. 0 points: No pain. 1-3 points: Mild pain (not affecting sleep). 4-6 points: Moderate pain (affects sleep but is tolerable). 7-10 points: Severe pain (extremely unbearable, seriously affecting sleep and daily life). | preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. |
This study will systematically monitor and record all adverse events and serious adverse events that occur from the start of treatment until the last follow-up. Adverse events refer to any adverse medical events that occur in patients after receiving treatment. These include, but are not limited to, common complications related to surgery, failure of cartilage repair, joint stiffness, and activity impairment. Serious adverse events include situations that result in death, endanger life, require hospitalization, cause significant functional impairment, or other important medical events.
| postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months. |