NCT07439107

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

December 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

December 6, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

Osteochondritis Dissecanstreatment

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • Tegner Activity Scale

    preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.

  • International Knee Documentation Committee (IKDC)-2000

    preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.

  • Lysholm Knee Score

    preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.

  • Visual Analog Scale

    preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.

Other Outcomes (3)

  • Height

    Preoperatively

  • Weight

    Preoperatively

  • AE/SAE

    postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.

Study Arms (2)

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)

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)

Interventions

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.

Conservative Management CohortSurgical Treatment Cohort

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The damaged cartilage and synovial tissues during the surgery may be preserved.

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

OsteochondritisBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

December 6, 2025

First Posted

February 27, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations