Management of Focal Cartilage Lesions of the Knee: The Benefits of an Autograft Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
Cartilage is a tissue whose primary function is to transmit and distribute loads when joints are under stress. It acts as a buffer between bones at the joints. Over time, or due to diseases and/or trauma, this surface can disappear, leading to pain and limited movement. Cartilage lesions are particularly difficult to treat because cartilage has a limited capacity for regeneration.
When cartilage lesions are characterized by a localized defect, several surgical techniques are available to restore cartilage tissue to the affected area.
The most frequently used surgical technique is bone marrow stimulation, also known as microfracture. The cartilage lesion is debrided, the subchondral bone exposed, and then a punch is used to perforate the subchondral bone, allowing a clot to form within the defect. This clot will proliferate and differentiate into scar tissue. However, this cellular differentiation results in fibrocartilaginous tissue rather than hyaline cartilage, sometimes with disappointing clinical outcomes.
Other techniques for cartilage restoration exist and are used routinely, including more biological techniques such as Minced Cartilage Implantation (MCI). Autologous cartilage is first harvested from around the defect, chopped into very small fragments, and then reimplanted. Cartilage fragmentation activates cell proliferation and migration, followed by the synthesis of an extracellular, cartilaginous matrix. The effectiveness of this fragmentation is increased with fine fragments (<0.3 mm). Cell proliferation and activity appear to be stimulated by the systematic addition of PRP (Platelet-Rich Plasma) during the MCI procedure.
The expected benefit of an MCI approach lies in clinical improvement and better cartilage regeneration (observed on imaging) compared to microfracture.
The objective is to conduct a controlled, randomized, blinded study (blinded to both the patient and the MRI assessor of the bone graft) to determine the benefit of an MCI approach versus microfracture.
详细描述
Objective : Primary objective: To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery.
Secondary objectives:
- To demonstrate the clinical benefit (based on functional scores and the need for re-intervention) of the MCI approach at different follow-up visits.
- To describe all post-operative complications.
- To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery in patients with lesions larger than 2 cm².
Outcome Measures :
Primary endpoint: Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged over 18 years.
- •Patient who has signed an informed consent form.
- •Patient with focal cartilage lesions of the knee, classified as grade 4 on MRI according to the International Cartilage Repair Society classification (exposure of subchondral bone), regardless of size, and for which surgery is indicated.
- •Be affiliated with or a beneficiary of a social security scheme.
排除标准
- •Revision knee surgery
- •Body Mass Index (BMI) > 27 kg/m²
- •Joint space narrowing on standard radiographic examination
- •Refusal of consent
- •Patient unable to read, write, or understand French
- •Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP)
- •Adult patient under guardianship, curatorship, or legal protection
- •Patient unable to give Personally, their consent according to Article L.1121-8 of the French Public Health Code (CSP) or an adult protected by law
- •Pregnant or breastfeeding woman according to Article L1121-5 of the French Public Health Code (CSP)
- •Patient who has already participated in a study within the last 12 months
- •Patient already enrolled in another ongoing clinical trial