Treatment Outcomes for Osteochondritis Dissecans of the Knee, Elbow and Ankle (OCD-MULTI): A Cohort Study
Treatment Outcomes for Osteochondritis Dissecans of the Knee, Elbow and Ankle in Patients Aged 6 to 18 Years: An Ambidirectional Cohort Study
This is a single-centre, non-randomized, observational, bidirectional (retrospective and prospective) cohort study conducted at the Department of Sports Medicine of Peking University Third Hospital, Beijing. It enrols patients aged 6 to 18 years with magnetic resonance imaging (MRI)-confirmed osteochondritis dissecans (OCD) of the knee, elbow or ankle. The planned first analysis cohort comprises 177 participants: a retrospective cohort of 77 patients treated between January 2016 and 26 October 2025, and a prospective cohort of at least 100 participants enrolled consecutively from 27 October 2025 under an open-ended (rolling) recruitment policy with no fixed recruitment closing date, contingent on continued ethics approval, cohort infrastructure and funding; the registered completion date is maintained as an estimated date and updated as rolling enrolment proceeds.
Based on the treatment actually received, participants are classified into a conservative treatment group or a surgical treatment group; the surgical group is further categorized into six standard techniques. All comparisons are stratified by the affected joint.
The primary outcomes at 24 months are: (1) the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score based on MRI in surgically treated participants; and (2) MRI-assessed stage regression in conservatively treated participants, using the Hefti staging for the knee, a five-stage T2-weighted MRI staging for the elbow (capitellum), and the Berndt-Harty classification (grades I, IIA, IIB, III and IV) for the ankle. Secondary outcomes are validated joint-specific functional measures (knee: IKDC Subjective Knee Form, Lysholm Knee Score and Tegner Activity Scale; elbow: Mayo Elbow Performance Score and QuickDASH; ankle: Foot and Ankle Outcome Score and AOFAS Ankle-Hindfoot Scale), pain on the visual analogue scale, reoperation and adverse events. All MRIs are independently read by radiologists/orthopaedic clinicians blinded to treatment assignment. Participants are followed for 24 months. The first locked prospective cohort (2030-12-31) forms the confirmatory analysis; participants enrolled after the first data-lock are analysed in prespecified periodic updates.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Design: This is a single-centre, non-randomized, observational ambidirectional cohort combining a retrospective cohort (patients treated from 1 January 2016 to 26 October 2025) with a consecutively enrolled prospective cohort (first participant enrolled 27 October 2025). The study is set in the Department of Sports Medicine of Peking University Third Hospital, and will be reported following the STROBE guideline. No treatment is assigned by the study; all treatment decisions are made by the treating clinician and patient according to current guidelines and individual circumstances, before and independently of study participation.
Participants: Males and females aged 6 to 18 years (inclusive) with a clinical and MRI diagnosis of OCD of the knee, elbow or ankle who receive treatment at the department are eligible. The prospective cohort uses non-probability consecutive sampling: every eligible, consenting patient is screened in chronological order and enrolled, with no fixed enrolment closing date. The retrospective cohort is identified from the institutional electronic medical record using the same eligibility criteria, with data extracted from existing records under a separate ethics approval.
Exposure definition: Participants are classified by the treatment actually received. Conservative management may include activity/sports restriction, bracing or short-term immobilization, protected weight-bearing, supervised physiotherapy, therapeutic ultrasound, analgesic/anti-inflammatory medication and traditional Chinese medicine. Surgical treatment comprises one of six standard procedures: (1) arthroscopic debridement; (2) fragment internal fixation; (3) subchondral/retroarticular drilling; (4) microfracture; (5) autogenous osteochondral transplantation; and (6) allogeneic osteochondral transplantation. Participants receiving multiple procedures are classified by the primary reconstructive procedure.
Imaging and staging: All joints undergo a standardized institutional MRI protocol at baseline and at 3, 6, 12 and 24 months. Lesion stability is staged on MRI using the Hefti system (stages I-V) for the knee, a five-stage T2-weighted MRI staging for the capitellum (I: normal contour with spotted high signal; II: more extensive high signal; III: discontinuity of the chondral surface without a high-signal interface; IV: a high-signal line separating the lesion; V: displacement or defect), and the Berndt-Harty classification for the talus (I: intact cartilage with subchondral injury; IIA: subchondral cyst; IIB: transverse fracture line without fragment; III: non-displaced fragment surrounded by fluid; IV: displaced fragment). MRIs are read independently by two readers blinded to treatment, with disagreement resolved by consensus or a third reader; inter-rater reliability is reported using the intraclass correlation coefficient.
Outcomes and schedule: The primary structural outcome is the 24-month MOCART score (0-100; higher scores indicate better morphological repair, >70 good and >85 excellent) in surgical participants, and MRI stage regression in conservative participants. Joint-specific functional scales and the pain VAS are recorded at baseline, treatment day, 7 days, and 3, 6, 12 and 24 months. Adverse and serious adverse events, complications, reoperation and concomitant treatment are monitored from treatment initiation through the last visit. Height and weight are measured at baseline.
Covariates: Baseline data include age, sex, height, weight and body mass index, affected side and joint, sports type/frequency/duration and trigger, comorbidities and concomitant medication. Skeletal maturity (immature versus mature) is determined from age and, when needed, radiographs and clinical physeal assessment. Lesion size (cm2 on MRI), intra-articular location and MRI stability are assessed by blinded evaluators. Lesion stability and skeletal maturity are prespecified effect modifiers; lesion size and joint are additional exploratory effect modifiers.
Governance: The study is sponsored by Peking University Third Hospital and overseen by a study management group chaired by the principal investigator, which reviews enrolment, data quality and adverse events at least annually and at every ethics renewal. Continuing recruitment is conditional on renewed ethics approval, maintained infrastructure and funding; the study will stop enrolling if approval or funding ceases, if the protocol can no longer be delivered to standard, or when a final analysis plan is adopted, without affecting follow-up of participants already enrolled.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Zhenglong Liu, Dr
- Numer telefonu: 86+13261993917
- E-mail: zhenlong_liu@bjmu.edu.cn
Lokalizacje studiów
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100191
- Rekrutacyjny
- Peking University Third Hospital
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Kontakt:
- Zhenlong Liu, Dr
- Numer telefonu: 13261993917
- E-mail: zhenlong_liu@bjmu.edu.cn
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
This study aims to establish a cohort for the treatment of osteochondritis dissecans (OCD) of the knee, elbow and ankle joint. The target population consists of patients with 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 18 years old (inclusive).
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: OTHER
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
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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). |
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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score in surgical treatment cohort
Ramy czasowe: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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In this study, the MOCART score quantitatively assesses cartilage/osteochondral repair on MRI across nine dimensions, including integrity of the repaired tissue, surface appearance, signal intensity and integration with surrounding tissue. The total score ranges from 0 to 100; higher scores indicate better morphological repair, with scores >70 defined as good and >85 as excellent. This primary outcome applies to surgically treated participants across the knee, elbow and ankle. |
preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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MRI stage regression in conservative treatment cohort
Ramy czasowe: preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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Stage regression of the OCD lesion on serial MRI in conservatively treated participants, assessed by readers blinded to treatment using the joint-specific validated system: the Hefti staging (stages I-V) for the knee, a five-stage T2-weighted MRI staging (stages I-V) for the elbow capitellum, and the Berndt-Harty classification (grades I, IIA, IIB, III and IV) for the talus. Stage regression (a decrease in stage from baseline) indicates structural healing/stabilization and is summarized as the proportion with regression and the change in stage at 24 months. |
preoperatively, and postoperatively at 3 months, 6 months, 12 months, and 24 months.
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Tegner Activity Scale
Ramy czasowe: 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. |
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
Ramy czasowe: 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. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Lysholm Knee Score
Ramy czasowe: 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. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Visual Analog Scale
Ramy czasowe: 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). |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Mayo Elbow Performance Score (MEPS)
Ramy czasowe: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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The Mayo Elbow Performance Score (MEPS) is a standardized clinician- and patient-reported composite outcome measure used to assess elbow-specific symptoms and functional impairment. It evaluates four domains: pain (0-45 points), range of motion/flexion-extension arc (0-20 points), joint stability (0-10 points), and ability to perform daily activities (0-25 points; combing hair, feeding, hygiene, donning shirt, donning shoes). The total score ranges from 0 to 100, with higher scores indicating better elbow function and less disability. Function classification: Excellent: 90-100 points; Good: 75-89 points; Fair: 60-74 points; Poor: <60 points. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Quick DASH
Ramy czasowe: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) is a shortened, validated patient-reported outcome measure assessing upper-extremity symptoms and functional impairment. It consists of 11 items covering difficulty with physical activities, pain, tingling, sleep disturbance, and limitations in work and social activities. Each item is rated on a 5-point Likert scale from 1 (no difficulty/no symptom) to 5 (unable/extreme symptom). At least 10 of 11 items must be completed for scoring. The score is transformed to a 0-100 scale using the formula: [(mean of completed items - 1) × 25]. The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates the most severe upper-extremity disability. Higher scores represent worse function. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Foot and Ankle Outcome Score (FAOS)
Ramy czasowe: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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The Foot and Ankle Outcome Score (FAOS) is a patient-reported outcome measure assessing foot- and ankle-related pain, symptoms, daily function, sports/recreation function, and quality of life. It consists of 42 items divided into five subscales: Pain (9 items), Other Symptoms (7 items), Activities of Daily Living (17 items), Sport and Recreation (5 items), and Foot- and Ankle-Related Quality of Life (4 items). Each item is scored on a 5-point Likert scale from 0 (no problem) to 4 (extreme problem). Each subscale is normalized to a 0-100 scale, where 100 indicates no symptoms or functional limitation and 0 indicates the worst possible state. Higher subscale scores indicate better foot and ankle function. A total FAOS score is not routinely derived; subscales are reported separately. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Ramy czasowe: preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale is a clinician- and patient-assessed composite measure evaluating clinical status of the ankle and hindfoot. It includes 9 items in three domains: Pain (1 item, 0-40 points), Function (7 items, 0-50 points; activity limitation/support, walking distance, walking surfaces, gait, sagittal motion, hindfoot motion, stability), and Alignment (1 item, 0-10 points). The total score ranges from 0 to 100, with 100 indicating no pain, full function, and good alignment. Higher scores indicate better clinical outcome. Commonly used classification: Excellent 90-100; Good 75-89; Fair 50-74; Poor <50. |
preoperatively and postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Wzrost
Ramy czasowe: Przedoperacyjnie
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Przedoperacyjnie
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Masa ciała
Ramy czasowe: Przedoperacyjnie
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Przedoperacyjnie
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AE/SAE
Ramy czasowe: 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. |
postoperatively at 7 days, 3 months, 6 months, 12 months, and 24 months.
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- BYSYDL2025034
- Peking University Third Hospit (Inny numer grantu/finansowania: BYSYDL2025034)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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