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RecruitingNCT05332288MAIOCDUpdated Sep 23, 2025

Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study

An observational study in Osteochondritis Dissecans Knee, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
15 Years to 40 Years
Sex
All
01

Study summary

The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The evaluation will be performed through clinical, subjective and objective assessments.

Read the detailed description

30 patients affected by OCD of the knee will be included in observational, perspective, monocentric trial. Patients will undergo clinical follow-up visits and administration of questionnaires before surgery and at 6, 12, 24 and 60 months after surgery. A CRF (Case Report Form) related to the patient's specific evaluation will be completed for each visit. Patients will also have imaging (MRI) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. Evaluation of the quality of cartilage repair will be assessed by specific MRI radiographic scores.

02

Conditions studied

  • Osteochondritis Dissecans Knee

Keywords

  • knee
  • OCD
  • Osteochondritis dissecans
  • scaffold
  • Maioregen
  • biomimetic
  • Osteochondral lesions
03

In context

Osteochondritis Dissecans

30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.

This study's planned enrollment of 30 is below the median of 130 across 12 observational studies indexed under Osteochondritis Dissecans.

Browse Osteochondritis Dissecans studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with knee OCD (ICRS OCD 3-4) with surgical indication for treatment of these lesions by biological reconstructive technique with osteochondral scaffolds will be enrolled. The estimated number of patients enrolled is 30, of which we expect from epidemiological data that about one third (10 patients) are between 15 and 18 years old.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patients, aged 15-40 years;
  • Single symptomatic osteochondral injury from OCD classified as ICRS OCD III or IV at the level of the femoral condyles;
  • Failure of conservative treatment
  • Lesion size between 1 and 10 cm2;
  • ≤ 30;
  • Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up.

Exclusion criteria

Exclusion Criteria:

  • -Additional grade III or IV cartilage injury on the knee being treated;
  • Advanced osteoarthritis
  • Systemic or localized infection
  • Systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases
  • Immune system disorders
  • Degenerative or vascular bone pathology (e.g. osteonecrosis)
  • Coagulation disorders
  • Systemic conditions that alter wound healing
  • Established allergy to equine collagen and calcium phosphate salts
  • Presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously;
  • Previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months;
  • Presence of any known , hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; Uncontrolled diabetes; Uncontrolled thyroid function changes; Uncontrolled metabolic disorders; Renal disease and hypercalcemia
  • Uncooperative patients, including those with a history of alcohol and drug abuse; Participation in another clinical trial or medical device trial that clinically interferes with the present pilot study;
  • Incapacitated patients;
  • Pregnant or lactating women. In particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hCG).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. IKDC-Subjective Score

    This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function

    Time frame: 24 months

Secondary outcomes

  1. IKDC-Subjective Score

    This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function

    Time frame: baseline, 6 months, 12 months, 60 months

  2. IKDC-Objective Score

    The objective rating scale has seven parameters related to knee function. The presence of effusions and degree of knee motion are assessed; the worst value of any of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee rated as normal, near normal, abnormal, and severely abnormal, respectively;

    Time frame: baseline, 6 months, 12 months, 24 months, 60 months

  3. KOOS Score

    KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items).

    Time frame: baseline, 6 months, 12 months, 24 months, 60 months

  4. TegnerActivity Level Scale

    Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level

    Time frame: baseline, 6 months, 12 months, 24 months, 60 months

  5. EQ-5D (EuroQoL) Current Health Assessment

    The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.

    Time frame: baseline, 6 months, 12 months, 24 months, 60 months

  6. Patient Acceptable Symptom State (PASS

    A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no"

    Time frame: baseline, 6 months, 12 months, 24 months, 60 months

  7. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score

    The MOCART score 2.0 is a data point of interest because it allows for the assessment of both the repair of the specific cartilage tissue and the structures surrounding it. The MOCART score 2.0 is based on nine variables measured on a standard MRI and summed to a score, ranging from 0 to 100, where 100 represents the best score and a score of 0 represents the worst score. The underlying factors that may influence the MOCART 2.0 score are the severity of the defect prior to cartilage repair surgery;

    Time frame: 12 months, 24 months, 60 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Andriolo L, Crawford DC, Reale D, Zaffagnini S, Candrian C, Cavicchioli A, Filardo G. Osteochondritis Dissecans of the Knee: Etiology and Pathogenetic Mechanisms. A Systematic Review. Cartilage. 2020 Jul;11(3):273-290. doi: 10.1177/1947603518786557. Epub 2018 Jul 12. PubMed 29998741 ↗
  • Andriolo L, Candrian C, Papio T, Cavicchioli A, Perdisa F, Filardo G. Osteochondritis Dissecans of the Knee - Conservative Treatment Strategies: A Systematic Review. Cartilage. 2019 Jul;10(3):267-277. doi: 10.1177/1947603518758435. Epub 2018 Feb 22. PubMed 29468901 ↗
  • Filardo G, Andriolo L, Soler F, Berruto M, Ferrua P, Verdonk P, Rongieras F, Crawford DC. Treatment of unstable knee osteochondritis dissecans in the young adult: results and limitations of surgical strategies-The advantages of allografts to address an osteochondral challenge. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1726-1738. doi: 10.1007/s00167-018-5316-5. Epub 2018 Dec 6. PubMed 30523367 ↗
  • Andriolo L, Di Martino A, Altamura SA, Boffa A, Poggi A, Busacca M, Zaffagnini S, Filardo G. Matrix-assisted chondrocyte transplantation with bone grafting for knee osteochondritis dissecans: stable results at 12 years. Knee Surg Sports Traumatol Arthrosc. 2021 Jun;29(6):1830-1840. doi: 10.1007/s00167-020-06230-y. Epub 2020 Aug 18. PubMed 32809120 ↗
  • Minas T, Ogura T, Headrick J, Bryant T. Autologous Chondrocyte Implantation "Sandwich" Technique Compared With Autologous Bone Grafting for Deep Osteochondral Lesions in the Knee. Am J Sports Med. 2018 Feb;46(2):322-332. doi: 10.1177/0363546517738000. Epub 2017 Nov 10. PubMed 29125919 ↗
  • Boffa A, Solaro L, Poggi A, Andriolo L, Reale D, Di Martino A. Multi-layer cell-free scaffolds for osteochondral defects of the knee: a systematic review and meta-analysis of clinical evidence. J Exp Orthop. 2021 Jul 30;8(1):56. doi: 10.1186/s40634-021-00377-4. PubMed 34331140 ↗
  • Kon E, Filardo G, Brittberg M, Busacca M, Condello V, Engebretsen L, Marlovits S, Niemeyer P, Platzer P, Posthumus M, Verdonk P, Verdonk R, Victor J, van der Merwe W, Widuchowski W, Zorzi C, Marcacci M. A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years. Knee Surg Sports Traumatol Arthrosc. 2018 Sep;26(9):2704-2715. doi: 10.1007/s00167-017-4707-3. Epub 2017 Sep 14. PubMed 28913600 ↗
  • Di Martino A, Perdisa F, Filardo G, Busacca M, Kon E, Marcacci M, Zaffagnini S. Cell-Free Biomimetic Osteochondral Scaffold for the Treatment of Knee Lesions: Clinical and Imaging Results at 10-Year Follow-up. Am J Sports Med. 2021 Aug;49(10):2645-2650. doi: 10.1177/03635465211029292. Epub 2021 Jul 20. PubMed 34283948 ↗
  • Sessa A, Perdisa F, Di Martino A, Zaffagnini S, Filardo G. Cell-Free Biomimetic Osteochondral Scaffold: Implantation Technique. JBJS Essent Surg Tech. 2019 Aug 14;9(3):e27. doi: 10.2106/JBJS.ST.18.00089. eCollection 2019 Jul-Sep. PubMed 32021725 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05332288
Responsible party
Sponsor
First posted
Apr 18, 2022
Start date
Apr 1, 2022
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Sep 23, 2025

Study contacts

Luca Andriolo, MD
Contact
luca.andriolo@ior.it
0516366567
Roberta Licciardi, MSc
Contact
roberta.licciardi@ior.it
6366567 ext. 051
Luca Andriolo, MD
principal investigator · Istituto Ortopedico Rizzoli

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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