Osteochondritis Dissecans KneeNCT07439107
Treatment Outcomes for Osteochondritis Dissecans of the Knee: A Cohort Study
An observational study of Osteochondritis Dissecans Knee and Osteochondritis Dissecans (OCD), run by Peking University Third Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Osteochondritis Dissecans Knee, Osteochondritis Dissecans (OCD)
- What is being tested?
- Clinical Management for OCD (Observed)
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
- Being tested
- Clinical Management for OCD (Observed)
- Keywords
- Osteochondritis Dissecans, treatment
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Clinical Management for OCD (Observed) | |
| 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. Receives: Other: Clinical Management for OCD (Observed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis Dissecans KneeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 254 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhenlong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439107
- Sponsor's protocol ID
- BYSYDL2025034
- Other IDs
- Peking University Third Hospit
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ambidirectional Cohort Study on Treatment Strategies for Osteochondritis Dissecans of the Knee
- ClinicalTrials.gov ID
- NCT07439107
- Acronym / sponsor ID
- BYSYDL2025034
- Keywords
- Osteochondritis Dissecans, treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Management Cohort | – | Other: Clinical Management for OCD (Observed)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). |
| Surgical Treatment Cohort | – | Other: Clinical Management for OCD (Observed)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. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Management for OCD (Observed)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. | Other | Conservative Management Cohort, Surgical Treatment Cohort |
Primary outcome
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Time frame: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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.
4 secondary outcomes
Tegner Activity Scale
Time frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
International Knee Documentation Committee (IKDC)-2000
Time frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
Lysholm Knee Score
Time frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
Visual Analog Scale
Time frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondritis Dissecans Knee and Osteochondritis Dissecans (OCD), run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score (time frame: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.