Clinical trial NCT05332288: Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Official title: Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondritis Dissecans Knee
Keywords: knee
OCD
Osteochondritis dissecans
scaffold
Maioregen
biomimetic
Osteochondral lesions
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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

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 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).

Primary outcomes:
measure: IKDC-Subjective Score
timeFrame: 24 months
Secondary outcomes:
measure: IKDC-Subjective Score
timeFrame: baseline, 6 months, 12 months, 60 months
measure: IKDC-Objective Score
timeFrame: baseline, 6 months, 12 months, 24 months, 60 months
measure: KOOS Score
timeFrame: baseline, 6 months, 12 months, 24 months, 60 months
measure: TegnerActivity Level Scale
timeFrame: baseline, 6 months, 12 months, 24 months, 60 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline, 6 months, 12 months, 24 months, 60 months
measure: Patient Acceptable Symptom State (PASS
timeFrame: baseline, 6 months, 12 months, 24 months, 60 months
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
timeFrame: 12 months, 24 months, 60 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Luca Andriolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.