Comparison Between Fresh Frozen Allograft With Bone Marrow Aspirate Versus Iliac Crest Autograft In Treatment Of Delayed Union And Non-union Of Long Bones.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the fracture union in both treatment groups using mRUST score (modified Radiographic Union Scale for Tibia).
研究概览
简要总结
Autologous iliac crest bone graft (ICBG) has long been considered the gold standard for the treatment of long bone non-unions due to its inherent osteogenic, osteo-inductive, and osteoconductive properties . However, harvesting ICBG is not without drawbacks. Donor site morbidity such as chronic pain, hematoma, infection, and gait disturbance has been reported in up to 20%-30% of patients, along with limitations in the volume of graft that can be safely harvested . In an effort to mitigate these challenges, biologic alternatives like Bone Marrow Aspirate (BMA) combined with cancellous allograft have gained attention. BMA is a rich source of mesenchymal stem cells (MSCs), hematopoietic stem cells, and growth factors such as bone morphogenetic proteins (BMPs) that contribute to osteogenesis. Fresh frozen cancellous allograft provides an osteoconductive scaffold but lacks viable cells and growth factors. When combined with BMA, it is hypothesized to mimic the biological properties of autograft while avoiding donor site complications. Despite promising early results in few studies, there is still a paucity of comparative studies evaluating the effectiveness of BMA with allograft against autologous ICBG in managing long bone delayed unions and non-unions. This study aims to bridge that gap by prospectively comparing the clinical and radiological outcomes between these two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of with delayed/non-unions of fracture of long bones (tibia/femur/humerus/ either or both forearm bones).
排除标准
- •1.Active systemic or local infections.
- •2.Fracture gap more than 4 cm (post-debridement) 3.Immunosuppressed patients 4.Uncontrolled diabetes mellitus.
- •5.Psychiatric illness.
- •6.Substance abuse.
结局指标
主要结局
To compare the fracture union in both treatment groups using mRUST score (modified Radiographic Union Scale for Tibia).
时间窗: 3 months , 6 months and 9 months
次要结局
- To assess the need for revision surgeries or additional interventions in each group.(Till 9 Months)
- To document the complication including infection, graft-related issues & etc.(Till 9 months.)
- To assess the VAS (Visual Analogue Score) at 48 hours, 2 weeks & 6 weeks post operative period.(48 hours, 2 weeks & 6 weeks post operative period.)
研究者
Abhishek Yadav
University College Of Medical Sciences and Guru Teg Bahadur Hospital , New Delhi.
