"One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- American Orthopaedic Foot and Ankle Society hindfoot score
研究概览
简要总结
BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying subchondral bone of the talar dome.
The use of concentrated bone marrow derived cells has been gaining successful results with arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells but also accessory cells that support angiogenesis and vasculogenesis by producing several growth factors.
OBJECTIVES Objective of this project is to identify the critical points of the regenerative treatment of osteochondral lesions of the ankle, in order to develop a standard and predictable procedure able to overcome the drawbacks of the previous techniques.
METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral lesion of the talus. The surgical procedure will be executed as following: the day before the surgery the platelet gel will be produced. The day of the surgery bone marrow will be aspirate from the posterior iliac crest and concentrated directly in the operating room by centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.
Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape.
After the scaffold implantation platelet gel will be sprayed on the top of implant, in order to provide extra growth factors and to improve the stability of the implant.
All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at maximum follow-up. Different score scales will be used to objectivate the clinical results (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI will be executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2 mapping will be performed at 24 months.
EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow derived cells (BMDCs) transplantation in a long term follow up study, with particular attention to identify the patient population that can gain the maximum benefit from this treatment, avoiding expensive and unnecessary procedures that too often are performed.
详细描述
Study design The study will be an observational prospective study. 46 patients previously operated in our center by Autologous Chondrocyte Implantation (ACI) will be used as control.
Patients 140 patients with osteochondral lesions of the talar dome will be recruited for this study. All the procedures will be performed according with specific European and Italian guidelines.
The patients will be operated as inpatients in the II Clinic of Orthopaedics and Traumatology. This is an highly specialized ward for the treatment of foot and ankle diseases. During the first day of hospitalization the patients will undergo a complete blood test and standard X-rays examination, along with specialized anesthesiologist, hematological and orthopaedic examinations.
Key inclusion and exclusion criteria Patients must satisfy the following inclusion criteria: osteochondral lesions of the talar dome ICRS grade III or IV lesion, size of the lesion >1.5 cm2, age <50 years.
Key exclusion criteria will take into account the presence of arthritis, kissing lesions, ankle malalignment and ankle instability, articular infections, hematological or rheumatic disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Osteochondral lesions of the talar dome
- •Presence of lesion classified as ICRS grade III or IV
- •size of the lesion >1.5 cm2
- •age <50 years
排除标准
- •Presence of osteoarthritis
- •presence of concomitant tibial lesion
- •presence of ankle malalignment
- •presence of ankle instability
- •presence of rheumatic diseases
结局指标
主要结局
American Orthopaedic Foot and Ankle Society hindfoot score
时间窗: 24 months after surgery
American Orthopaedic Foot and Ankle Society hindfoot score will be used to assess the quality of life of the patients with a minimum score of 0 and a maximum of 100.
次要结局
- T2 mapping MRI value(12 and 24 months after surgery)