An Observational, Prospective, Multicentre Study of Patients With Outerbridge Grade III / IV Chondral and/or Osteochondral Defects of the Knee Treated With Nanofractured Autologous Matrix-induced Chondrogenesis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Amount of tissue repaired
研究概览
简要总结
It is a prospective observational study of hospital cases. The objective is to determine the decrease of lesion size and the regeneration of chondral tissue in femoral condyle cartilage defect treated with NAMIC.
24 patients will be included
详细描述
Background: The treatment of chondral lesions remains a challenge for orthopaedic surgeons. They are most common in young active individuals and result in substantial impairment of quality of life. The conventional joint treatment methods available to date, such as Pridie-type perforations, microfractures using open or arthroscopic approaches and mosaicoplasty are far from satisfactory. Cell-based therapies have also been tested in more advanced research centres.
Nanofractured autologous matrix-induced chondrogenesis (NAMIC) is a simple, easily reproducible implantation technique that can be performed in most hospitals to improve clinical outcomes of patients with severe chondral lesions.
The present observational, multicentre study is based on the recently published NAMIC© technique (Behrens_Bentin_06_2015 The Knee) that reports significant improvements over previous techniques, especially regarding the reduction of rehabilitation period. Our main aim is to confirm these results in a larger sample.
NAMIC is a matrix-guided minimally invasive stimulation of the subchondral bone marrow.
The present study will collect data on the usual medical practice when the NAMIC technique is used to treat grade III or IV symptomatic focal cartilage lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Outerbridge grade III or IV cartilage lesions localized in the medial or lateral condyle of the knee (Chondral lesions were diagnosed by magnetic resonance T2 mapping and graded according to the Outerbridge classification.).
- •Size of lesion between 1.5 cm2 and 6 cm2 (specify size, alignment, and telemetry)
- •Body mass index ≤ 30 kg/m
- •Stable or stabilized knee, with normal axis (<+/-5º)
- •The patients included in the study will accept to follow the recommended physiotherapy programme, including exercises to be performed at home.
排除标准
- •Any disease that, in the opinion of the investigator, may prevent the patient from completing the study or interfere with the assessment of the efficacy or security of the treatment proposed.
- •Patients with any disorder of coagulation of the blood or receiving anticoagulant therapy.
- •Patients with rheumatoid arthritis, bi- or tri-compartmental arthritis such as chondrocalcinosis and gout.
- •Malalignment of affected leg with valgus or varus > 5º (and/or > vs. contralateral leg)
- •Chondral lesion of the tibial plateau (mirror lesions).
- •Known allergy to metal (nitinol or stainless steel) and/or pork products.
- •Any general pathology that may not allow long-term data collection.
结局指标
主要结局
Amount of tissue repaired
时间窗: 12 months
Amount of tissue repaired, calculating the filling area of the lesion. Magnetic resonance will be used to determine the filling area at 12-month outpatient follow-up visit.
次要结局
- Size of the lesion(preoperative, and at 12 months)
- Mechanical alignment(preoperative, and at 12 months)
- Localisation of the lesion(preoperative, and at 12 months)
- Pain in the knee: Visual Analogue Scale(preoperative, and at 12 months)
- Activity level: Tegner Activity Scale(preoperative, and at 12 months)
- Surgeries of cartilage or that may directly or indirectly affect cartilage(12 months)
- KOOS score(preoperative, and at 12 months)
研究者
Jordi Villalba Modol
Doctor
Corporacion Parc Tauli