- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439107
Treatment Outcomes for Osteochondritis Dissecans of the Knee: A Cohort Study
An Ambidirectional Cohort Study on Treatment Strategies for Osteochondritis Dissecans of the Knee
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of osteochondritis dissecans of the knee;
- No participation in any other clinical trial within the past 3 months;
- Voluntary participation, provision of signed informed consent, and ability to comply with the clinical follow-up schedule.
Exclusion Criteria:
- Regular use of sedatives, hypnotics, anxiolytics, or other addictive substances;
- Presence of severe primary diseases in the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders;
- Inability or unwillingness to undergo prolonged and intensive postoperative rehabilitation;
- Females who are planning pregnancy within the next 12 months, or who are currently breastfeeding or pregnant;
- Individuals with specific beliefs or restrictions that preclude the use of medical devices derived from porcine sources (as some grafts/devices are porcine-derived);
- Contraindications to Magnetic Resonance Imaging (MRI) examination;
- Individuals with psychiatric disorders impairing decision-making capacity, or any other condition deemed by the investigator to make participation inadvisable.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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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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.
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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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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Time Frame: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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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.
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preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tegner Activity Scale
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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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.
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preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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International Knee Documentation Committee (IKDC)-2000
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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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.
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preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Lysholm Knee Score
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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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.
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preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Visual Analog Scale
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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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).
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preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Height
Time Frame: Preoperatively
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Preoperatively
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Weight
Time Frame: Preoperatively
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Preoperatively
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AE/SAE
Time Frame: postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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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.
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postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BYSYDL2025034
- Peking University Third Hospit (Other Grant/Funding Number: BYSYDL2025034)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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