Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- IKDC-subjective score (International Knee Documentation Committee)
研究概览
简要总结
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
详细描述
The anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. The mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament.
The treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions.
In order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 < age < 55;
- •Patients with complete ACL injury candidates for surgical reconstruction of the same;
- •Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively;
- •Patients without evidence of osteoarthritis
- •Patients' ability and consent to participate in clinical and radiological follow-up;
- •Signature of informed consent.
排除标准
- •Patients incapable of understanding and of wanting;
- •State of immunodepression;
- •Patients with malignant neoplasms;
- •Patients suffering from rheumatic diseases;
- •Patients suffering from non-compensated diabetes;
- •Patients suffering from uncompensated thyroid metabolic disorders;
- •Patients abusing alcoholic beverages, drugs or drugs;
- •Patients with axial deviations> 5 °;
- •Body Mass Index> 35;
- •Patients treated with surgery at the same knee in the previous 12 months.
- •Cartilaginous lesions grade I-II according to the ICRS score.
- •Cartilage lesions with a diameter greater than 3 cm².
- •Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment.
- •Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.
研究组 & 干预措施
no treatment of the cartilaginous lesions
Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated
干预措施: no treatment cartilaginous lesions (Procedure)
Nanofractures treatment of the cartilaginous lesions
Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.
干预措施: Nanofractures (Procedure)
结局指标
主要结局
IKDC-subjective score (International Knee Documentation Committee)
时间窗: 24 month
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
时间窗: 24 month
Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium)
次要结局
- EQ-5D (EuroQoL) Current Health Assessment(6, 12, 24, 36 and 60 months)
- Tegner Activity Level Scale(6, 12, 24, 36 and 60 months)
- KOOS (Knee injury and Osteoarthritis Outcome Score )(6, 12, 24, 36 and 60 months)
- IKDC-subjective score (International Knee Documentation Committee)(6, 12, 36 and 60 months)