Assessment of Using Mixture of Cancellous Bone Autograft, Bone Substitute, Local Antibiotic and Fresh Blood as Effective Onlay Graft for Ununited Fixed Femoral and Tibial Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Radiographic union of the fractures
研究概览
简要总结
This study aimed to assess the clinical and radiological outcomes of the usage of autogenous bone graft mixed with bone substitute, fresh blood of patient and local antibiotic used as an onlay graft in treatment of nonunion or delayed union of fixed femoral and tibia fractures.
详细描述
Fractures of long bones as femur and tibia are the third most common ones in orthopedics daily practice, these fractures are usually treated with intramedullary nails.
Union is defined as the appearance bridging callus more than two cortices at the fracture site in the expected time frame for each fracture type which is about 25 weeks for long bones. Nonunion is a problem that has an impact on both patients and society as it may lead to depression, longer time-off work, poor functional outcomes, and cost burdens of secondary interventions to manage.
Different strategies can be used for treatment of such cases. All measures used should follow the diamond concept which summarizes the core factors that need to be present to achieve bone healing. In particular, these factors relate to the optimization of the mechanical stability and biological environment (sufficient osteogenic and angiogenic cells, osteoconductive scaffolds and growth factors).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 70 years old.
- •Both sexes.
- •Patients with complete radiographic and clinical follow-up records for at least 12 months post-revision.
排除标准
- •- Patients with pathological fractures, infection, or comorbidities that interfere with healing.
研究组 & 干预措施
Study group
Adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators
干预措施: Revision using a composite graft (Procedure)
结局指标
主要结局
Radiographic union of the fractures
时间窗: 6 months post-procedure
Radiographic follow-up included evaluating Radiographic Union Score for Tibial Fractures (RUST) were used system to objectively evaluate tibial fractures. RUST assesses union based on four radiographic features: the presence of callus formation, cortical bridging, trabecular bridging, and the degree of alignment at the fracture site. Each feature was scored individually on a scale of 0 to 4, with higher scores indicating better healing.
次要结局
- Time to union(Till full fracture healing (Up to 6 months))
- Degree of pain(12 months post-procedure)
- Incidence of postoperative complications(12 months post-procedure)
研究者
Ahmed Gamal Ismaiel
Lecturer of Orthopedic Surgery, Tanta University, Tanta, Egypt
Tanta University