An interventional study of osteochondral scaffold implant and SSOC in Osteochondral Lesions of the Knee Joint, Osteochondritis Dissecans (OCD) and Early Osteoarthritis, sponsored by Fin-Ceramica Faenza Spa. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Fin-Ceramica Faenza Spa · Not applicable, Interventional, and Treatment
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.
This is multicenter, prospective, randomized clinical trial, subjects will be randomized (2:1) to MaioRegen Prime or debridement.
All randomized patients will be followed with post-operative visits at 15 days, 6 weeks, 3, 6, 12, 18 and 24 months after surgery and annually post-24 months visit (until last patient reaches 24 months).
During screening period and at follow-up visits commonly used specific scores will be evaluated: IKDC Subjective Knee Evaluation Form, IKDC Knee Examination Form, KOOS, Tegner Score, VAS pain, PROMIS-29, ICRS Cartilage Repair Assessment and MRI related scores.
Exclusion Criteria:
Medical Device: MaioRegen Prime implant
Device: osteochondral scaffold implant
Debridement
Procedure: SSOC
three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
Debridement
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
Time frame: baseline, 24 months
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 24 months of MaioRegen Prime compared to debridement
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. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
Time frame: 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
The new IKDC Subjective Knee Evaluation Form, published in 2000, 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. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
Time frame: baseline, 24 months
Proportion of patients without SAEs related to MaioRegen treatment or debridement treatment during the 24-month follow-up period
Time frame: baseline, 24 months
Proportion of patients without related re-intervention after MaioRegen treatment or debridement treatment at 24 month follow-up period
Time frame: baseline, 24 months
Change from baseline in average overall KOOS score (Knee Injury and Osteoarthritis Outcome 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). Each question uses a 0 (no problem/difficulty) to 4 (extreme problem/difficulty) response, which is then converted into the final 0-100 score for each subscale, indicating the percentage of the total possible score achieved, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Time frame: baseline, 12, 18, and 24 months
Change from pre-injury and from baseline in Tegner score
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, where 0 is being on sick leave/disabled due to knee issues, and 10 is elite, international competitive sports.
Time frame: baseline, 12 months, 18 months, 24 months
Change from baseline in IKDC (International Knee Documentation Committee) Knee Examination Objective Form
The IKDC objective examination form uses a 0-100 scale, calculated by summing 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.
Time frame: baseline, 12 months, 18 months, 24 months
Change from baseline in VAS (visual analogue scale) pain
The VAS scale is a 0-cm line tool to measure pain intensity, with "no pain" at 0 and "worst pain imaginable" at 10, where patients mark their pain level
Time frame: baseline, 12 months, 18 months, 24 months
PROMIS-29 (Patient-Reported Outcomes Measurement Information System): Patient's QOL (quality of life) improvement
The PROMIS-29 uses a T-score metric (mean 50, SD 10) to assess 7 domains (Physical Function, Fatigue, Depression, Anxiety, Pain Interference, Sleep Disturbance, and Social Participation) with 4 questions with an additional pain intensity numeric rating scale (NRS, 0-10 score). There is no total score, but each axis forms its own score.
Time frame: baseline, 12 months, 18 months and 24 months
MRI evaluation: MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score
MOCART 2.0 score allows the assessment of both cartilage tissue repair and the structures surrounding it. It is a 0-100 point MRI-based system for evaluating cartilage repair, updating the original MOCART by focusing on nine key variables like defect filling (in 25% increments), integration to native cartilage, surface, signal intensity, bony changes (overgrowth/defect), marrow edema, and subchondral cysts. 100 represents the best score and a score of 0 represents the worst score.
Time frame: baseline, 12 months, 24 months
Safety Outcome
Adverse Events rate per type, severity, seriousness, and relatedness to the treatment, including Serious Adverse Events and Serious Adverse Device Effect, Adverse Device Effect, Unanticipated Adverse Device Effect, Re-operations, Complaint and Treatment Failures up to 24 months will be evaluated and adjudicated by CEC members.
Time frame: 24 monhs
Plan to share: No
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