Treatment Outcomes for Osteochondritis Dissecans of the Knee: A Cohort Study

February 26, 2026 updated by: Liu Zhenlong, Peking University Third Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tegner Activity Scale
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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.
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.
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
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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
Time Frame: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Preoperatively
Preoperatively
Weight
Time Frame: Preoperatively
Preoperatively
AE/SAE
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BYSYDL2025034
  • Peking University Third Hospit (Other Grant/Funding Number: BYSYDL2025034)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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