NCT07332182尚未招募不适用
Multicenter Prospective Randomized Study of MaioRegenTM Prime vs. Debridement (Surgical Standard of Care (SSOC)) for the Treatment of Osteochondral Lesion of the Knee Joint - OSTEOCONFIRM Study
Fin-Ceramica Faenza Spa0 个研究点目标入组 400 人开始时间: 2026年5月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Superiority of MaioRegen Prime vs Debridement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
CEC (clinical event committee) board members will be blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Intra-articular steroid injections within 3 months;
- •Any previous cartilage repair procedure (such as: microfracture, Osteochondral autograft transplantation system (OATS), Autologous Matrix Induced Chondrogenesis, (AMIC), Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee within one year or debridement within 6 months;
- •Patients affected by osteoporosis (established through x-ray tests, called DEXA scans, bone density, etc. Criteria for osteoporosis: T-score is < - 2.5 SD), chondrodysplasia, or osteogenesis imperfecta;
- •Patients affected by known allergy to equine collagen or calcium-phosphates;
- •Patients who underwent chemotherapy in the past 12 months;
- •Patients with a known history of any significant systemic disease (such as but not limited to: HIV, hepatitis, HTLV, syphilis, coagulopathies, insulin dependent diabetes mellitus etc.) or affected by a significant malignancy;
- •Participation in other clinical trials within 90 days prior to the study or concurrent with the study;
- •Patient who is pregnant (or intends to become pregnant within one-year post-op) or breastfeeding;
- •Known drugs or alcohol abuse;
- •Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other);
- •Any known history of intra-articular or osseous infection of the index knee;
- •Patients affected by a known history of inflammatory arthropathy or crystal-deposition arthropathy;
- •The existence of any surgical or medical condition that, in the judgement of the Investigator, might compromise patient safety or the outcome of the study;
- •Any medical conditions or implants that would prevent the participant from undergoing an MRI, including but not limited to pacemakers, clips, cochlear implants, or metal shrapnel.
研究组 & 干预措施
MaioRegen Prime
Experimental
Medical Device: MaioRegen Prime implant
干预措施: osteochondral scaffold implant (Device)
Surgical Standard of Care (SSOC)
Active Comparator
Debridement
干预措施: SSOC (Procedure)
结局指标
主要结局
Superiority of MaioRegen Prime vs Debridement
时间窗: baseline, 24 months
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
次要结局
- 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)
- Change from pre-injury and from baseline in Tegner score(baseline, 12 months, 18 months, 24 months)
- Change from baseline in IKDC (International Knee Documentation Committee) Knee Examination Objective Form(baseline, 12 months, 18 months, 24 months)
- Change from baseline in VAS (visual analogue scale) pain(baseline, 12 months, 18 months, 24 months)
- PROMIS-29 (Patient-Reported Outcomes Measurement Information System): Patient's QOL (quality of life) improvement(baseline, 12 months, 18 months and 24 months)
- MRI evaluation: MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score(baseline, 12 months, 24 months)
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