A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to healing
研究概览
简要总结
A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65, skeletally mature adults.
- •Acute unilateral closed tibia diaphyseal fractures as the primary injury.
- •Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
- •Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.
排除标准
- •Open/compound tibial fracture.
- •Fracture Type 42-C2 according to Muller AO classification.
- •Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
- •Polytrauma (defined as injury severity score of 17 or more.)
- •Prior or concomitant illnesses that may affect healing.
- •Exposure to drugs that can affect the bone metabolic state within the past three months.
- •Receiving chemotherapy, radiation treatment or immunosuppression drugs.
- •Currently enrolled in any other study which may impact on the results of the present study.
- •If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.
研究组 & 干预措施
Control
Patients will undergo operative procedure with no additional intervention.
Study
Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation.
干预措施: Concentrated autologous PRP-BMA (Other)
结局指标
主要结局
Time to healing
时间窗: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks
Healing will be assessed both clinically and radiologically (RUST score)
次要结局
未报告次要终点
研究者
PeterGiannoudis
Professor
University of Leeds