Efficacy of bone marrow aspirate concentrate (BMAC) as compared to autograft in achieving spinal fusion in patients undergoing single level transforaminal lumbar interbody fusion (TLIF) - a Pilot RCT
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Transforaminal lumbar interbody fusion (TLIF) is an established approach to spinal fusion surgery that involves accessing the lower spine through the inter-vertebral foramina. The vertebral disc is subsequently removed, and a bone graft is placed to fuse the adjacent vertebral bodies. However, Autograft is considered the biologically most suitable graft material due to its osteogenic and osteoconductive properties. The use bone graft in spine surgeries mainly targeted to achieve bone healing and fusion between the affected vertebrae. Most of studies point out that autograft contributes to good fusion rates, and decreases the need of re operation.
Although studies have highlighted the postoperative complications and patient dis-satisfaction due to discomfort from the harvest site. Therefore, there has been a large push to discover alternative bone graft fusion materials.
Several options have gained substantial attention and are being studied to determine their efficacy. With the modernization of biotechnology, there has been a concerted effort to develop novel biomaterials that can be used to augment spine surgery.
An alternative method is the use of BMA, a method that has become popular in Orthopaedics at the end of the last century and the beginning of the present. This orthobiologic product has been used in many treatments of some musculoskeletal disorders, such as non-union, bone defects, arthritis, ligament tears, and osteonecrosis of the femoral head.
BMAC from patient own bone marrow contain stem cell and growth factor that promote healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18-65 Years Patients undergoing single level TLIF.
排除标准
- •Previous spinal surgery at the same level Presence of infection or malignancy in the spine Presence of infection or malignancy at the donor site.
研究者
Dr MOHAMMED IRFAN M P
JIPMER, Puducherry
