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

Osteochondritis Dissecans Knee Clinical Trial

— MAIOCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332288
• Other study ID #: MAIOCD
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 2029

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Luca Andriolo, MD
• Phone: 0516366567
• Email: luca.andriolo[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2029
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans
• Osteochondritis Dissecans Knee

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	baseline, 6 months, 12 months, 60 months
Secondary	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;	baseline, 6 months, 12 months, 24 months, 60 months
Secondary	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).	baseline, 6 months, 12 months, 24 months, 60 months
Secondary	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	baseline, 6 months, 12 months, 24 months, 60 months
Secondary	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.	baseline, 6 months, 12 months, 24 months, 60 months
Secondary	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"	baseline, 6 months, 12 months, 24 months, 60 months
Secondary	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;	12 months, 24 months, 60 months