MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee

NCT07332182 | Not Yet Recruiting FDA Device

• 1 other identifier: ORT-24
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee joint. The foreseen population involves patients with osteochondral lesions with different etiology, dimension, shape, and location. The evaluation will be performed through clinical, subjective and objective assessments.

Conditions

Osteochondral Lesions of the Knee Joint; Osteochondritis Dissecans (OCD); Early Osteoarthritis

Keywords

osteochondral lesion; MaioRegen Prime; OCD; knee; scaffold; biomimetic

Outcome Measures

Primary Outcomes (1)

• Superiority of MaioRegen Prime vs Debridement

  The primary endpoint is the success rate defined as a composite binary endpoint, where a patient is a success if they meet all of the following criteria: * At least a 15 points IKDC increase at 24 months * Lack of SAE related to MaioRegen treatment or debridement during the 24-month follow-up * Lack of related re-intervention after MaioRegen treatment or debridement during the 24-month follow-up

  baseline, 24 months

Secondary Outcomes (10)

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 24 months of MaioRegen Prime compared to debridement

  baseline, 24 months

• Rate of responder in IKDC Subjective Knee Evaluation at 24 months of MaioRegen Prime compared to debridement as defined as improvement in IKDC Subjective Knee Evaluation of ≥15 points

  baseline, 24 months

• Proportion of patients without SAEs related to MaioRegen treatment or debridement treatment during the 24-month follow-up period

  baseline, 24 months

• Proportion of patients without related re-intervention after MaioRegen treatment or debridement treatment at 24 month follow-up period

  baseline, 24 months

• Change from baseline in average overall KOOS score (Knee Injury and Osteoarthritis Outcome Score)

  baseline, 12, 18, and 24 months

Other Outcomes (1)

• Safety Outcome

  24 monhs

Study Arms (2)

MaioRegen Prime

EXPERIMENTAL

Medical Device: MaioRegen Prime implant

Device: osteochondral scaffold implant

Surgical Standard of Care (SSOC)

ACTIVE COMPARATOR

Debridement

Procedure: SSOC

Interventions

osteochondral scaffold implant DEVICE

three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee

MaioRegen Prime

SSOC PROCEDURE

Debridement

Surgical Standard of Care (SSOC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent prior to any study-related procedures;
• Male or female patients aged between 18 and 60 years (inclusive);
• Body Mass Index (BMI) ≤ 35;
• Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as determined by baseline MRI);
• Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;
• Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);
• IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
• Non-responsive to physical therapy for at least 6 weeks;
• Patients physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits.

You may not qualify if:

• IKDC subjective score at Baseline is more than or equal to 70;
• KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
• Osteochondral tibial plateau and/or patella defects;
• Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
• Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
• Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
• Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;
• Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.
• Patients previously treated for total or partial meniscectomy in the specific index knee compartments (more than 50% of the meniscus in the index compartments is missing);
• Patient requiring total or partial meniscectomy to be performed concomitantly, involving more than 50% of one or both menisci in the index knee compartment (lack of functional remaining meniscus, at least 5mm rim at the end of the procedure); and patient requiring ligamentoplasty and high tibial osteotomy (HTO) to be performed concomitantly;
• Untreated knee ligament instability or treated within 6 months;
• Kissing (counterposed) osteochondral lesions;
• Significant instability of the index knee according to IKDC Knee Examination Form 2000: Grade C (abnormal) or D (severely abnormal).
• Patients affected by any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with the evaluation of the index knee;
• Patients affected by bilateral knee lesions that need treatment;

Sponsors & Collaborators

• Fin-Ceramica Faenza Spa: lead

MeSH Terms

Conditions

Osteochondritis Dissecans; Osteoarthritis

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Central Study Contacts

Simal Trikam, Clinical Trial Manager

CONTACT

+44 7889983972; strikam@mcra.com

Roberta Miale, MEng

CONTACT

+39 0546645438; roberta.miale@finceramica.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: CEC (clinical event committee) board members will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2031
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share