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

NCT05332288 | Recruiting

• 1 other identifier: MAIOCD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteochondritis Dissecans Knee

Keywords

knee; OCD; Osteochondritis dissecans; scaffold; Maioregen; biomimetic; Osteochondral lesions

Outcome Measures

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

  24 months

Secondary Outcomes (7)

• IKDC-Subjective Score

  baseline, 6 months, 12 months, 60 months

• IKDC-Objective Score

  baseline, 6 months, 12 months, 24 months, 60 months

• KOOS Score

  baseline, 6 months, 12 months, 24 months, 60 months

• TegnerActivity Level Scale

  baseline, 6 months, 12 months, 24 months, 60 months

• EQ-5D (EuroQoL) Current Health Assessment

  baseline, 6 months, 12 months, 24 months, 60 months

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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;
• BMI ≤ 30;
• Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up.

You may not qualify if:

• 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 human immunodeficiency virus, 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).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 29998741 BACKGROUND

• 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.

  PMID: 29468901 BACKGROUND

• 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.

  PMID: 30523367 BACKGROUND

• 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.

  PMID: 32809120 BACKGROUND

• 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.

  PMID: 29125919 BACKGROUND

• 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.

  PMID: 34331140 BACKGROUND

• 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.

  PMID: 28913600 BACKGROUND

• 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.

  PMID: 34283948 BACKGROUND

• 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.

  PMID: 32021725 BACKGROUND

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Luca Andriolo, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Andriolo, MD

CONTACT

0516366567; luca.andriolo@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)