Elastic Stable Intramedullary Nailing of Forearm Shaft Fractures by Titanium Compared With Biodegradable Nails: Results of a Prospective Randomized Trial in Children With at Least Two Years of Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The range of motion (ROM) of forearm measured by goniometer
研究概览
简要总结
There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft fractures, such as soft tissue irritation and the need of implant removal. A new mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has been developed. The nails are tapped into the medullary cavity and left in place. The aim of this study was to compare BESIN technique with ESIN.
This is a prospective, randomized, controlled clinical trial including the patients (aged 5-15 years) who required operative treatment for forearm shaft fractures in two pediatric trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN. Thirteen patients were required for each group, according to power analysis but altogether 35 were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd, USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were primary outcomes. Radiographs and potential complications were analyzed of all and magnetic resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).
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
盲法说明
The patient was informed about the treatment method that he or she was randomised. The operating surgeon knew the group and treatment that the patient belonged to.
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •suffering from single- or both-bone forearm shaft fracture
- •child patient , age from 5 to 15 years
- •surgical fixation needed, fracture is unstable
- •cast immobilization is not rigid enough for the fracture treatment
排除标准
- •open fractures with significant soft-tissue injury
- •pathological fractures
- •if patient has a previous fracture or infection in the same forearm
- •patients with metabolic bone diseases, systematic disease
- •patient uses the medication affecting bone quality
- •resistance to infection
- •fractures older than 7 days
研究组 & 干预措施
PLGA implant, Bioretec ltd. Finland
Treatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population
干预措施: PLGA implant, Bioretec ltd. Finland (Device)
Titanium elastic stable nail
Treatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population
干预措施: Titanium elastic stable nail (Device)
结局指标
主要结局
The range of motion (ROM) of forearm measured by goniometer
时间窗: 2 years
The ROMs of forearm
次要结局
- Implant degeneration in Magnetic resonance imagining(2 years)
- Pain measured with visual analogue scale(2 years)
- Radiographic bone union(2 years)
- Radiographic bone deformity(2 years)
- Magnetic resonance imagining, bone healing(2 years)
- The range of motion (ROM) of elbow and wrist measured by goniometer(2 years)
- Magnetic resonance imagining, soft tissue reaction(2 years)
研究者
Jaakko Sinikumpu
Head of childhood fracture and sport injury study, M.D., Ph.D.
Oulu University Hospital