Transverse Pinning Versus Antegrade Intramedullary Pinning for Neck and Shaft Metatarsal Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ⦁ Time to bone union
研究概览
简要总结
The aim of this prospective randomized controlled clinical trial study is to compare clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures
详细描述
Metatarsal fractures account for 35% of fractures of the foot and 5% of all skeletal fractures. They may be single or multiple, and isolated or associated with ligament lesions around the tarsometatarsal joint or with other fractures (1).
Metatarsal fractures result from low-energy trauma in almost 85% of cases. Crush injury accounts for 41% of high-energy foot trauma. Fatigue fracture of metatarsals account for 38% of all fatigue fractures. The second and third metatarsals (M2, M3) are the most affected (2). The fifth metatarsal is involved in up to 70% of metatarsal fractures and approximately 80% of these are proximal (3).
The overall aim of treatment is to restore the alignment of the metatarsals thereby maintaining the longitudinal and transverse arches of the forefoot. This allows normal weight distribution under the metatarsal heads. Nondisplaced fractures and fractures of the second to fourth metatarsals with displacement in the axial plane can be treated conservatively with protected weight bearing in a hard-soled shoe or boot for 4-6 weeks.
Several surgical methods have been introduced to treat displaced fractures when satisfactory reduction and stability cannot be obtained by closed reduction techniques. Among the various surgical techniques available for the fixation of metatarsal fractures, include open reduction internal fixation by screw or mini plate , transverse pinning and antegrade intramedullary pinning Transverse pinning and antegrade intramedullary pinning have gained widespread acceptance due to their minimally invasive stabilization of metatarsal fractures to enable adequate fracture healing in a correct position to restore anatomy and biomechanics of the foot (4).
Antegrade intramedullary pinning technique using Kirschner wire (K-wire) allowed displaced metatarsal fractures to be easily reduced without opening the fracture site, and at the same time secured firm fixation without infringing the metatarsophalangeal (MTP) joint. Furthermore, the described method allowed immediate joint motion and caused no motion or pain limitation, and thus allowed rapid return to daily activities (5).
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
- None
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
- •⦁ Age ≥ 18 years.
- •Both sexes.
- •Displaced metatarsal neck or shaft fractures.
- •Unstable fracture for which reduction could not be maintained after closed reduction.
- •Open fractures
排除标准
- •⦁ Fractures combined with Lisfranc injury.
- •Other concomitant fractures.
- •Non displaced fracture
研究组 & 干预措施
group A
⦁ Group A: 20 patients who will be treated by transverse pinning for neck or shaft metatarsal fractures
干预措施: Transverse Pinning for neck and shaft Metatarsal Fractures (Procedure)
group B
⦁ Group B: 20 patients who will be treated by antegrade intramedullary pinning for neck or shaft metatarsal fractures.
干预措施: Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures (Procedure)
结局指标
主要结局
⦁ Time to bone union
时间窗: 12 weeks
Immediate motion of the MTP joint and partial weightbearing in a stiff-soled shoe will be allowed. full weightbearing will be permitted 4 weeks after the operation. K-wires will be removed when pain subsided, which will be usually at 6 to 8 weeks for metatarsal head or neck fractures. For metatarsal shaft fractures, K-wires will be removed 3 months after the operation. union will be confirmed in radiographs taken at 12 weeks. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.
次要结局
- ⦁ Foot function using the Foot and Ankle Ability Measure (FAAM)(6 months)
- ⦁ Pain intensity using the visual analog scale (VAS)(6 months)
- ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications.(6 months)
研究者
Alaa Abdelrahman Abdelrasheed
orthopedic resident
Sohag University
