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

Официальное название

Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• IKDC-Subjective Score [Срок оценки: 24 months]

Вторичные конечные точки (7)

• IKDC-Subjective Score [Срок оценки: baseline, 6 months, 12 months, 60 months]
• IKDC-Objective Score [Срок оценки: baseline, 6 months, 12 months, 24 months, 60 months]
• KOOS Score [Срок оценки: baseline, 6 months, 12 months, 24 months, 60 months]
• TegnerActivity Level Scale [Срок оценки: baseline, 6 months, 12 months, 24 months, 60 months]
• EQ-5D (EuroQoL) Current Health Assessment [Срок оценки: baseline, 6 months, 12 months, 24 months, 60 months]
• Patient Acceptable Symptom State (PASS [Срок оценки: baseline, 6 months, 12 months, 24 months, 60 months]
• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score [Срок оценки: 12 months, 24 months, 60 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• -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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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 PMID 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. PMID 34283948

Идентификаторы

NCT: NCT05332288 · MAIOCD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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