A Prospective, Single Center, Single Group, Open-label Study to Evaluate the Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Requiring Internal Fixation Due to Hand Fractures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Bone union
研究概览
简要总结
This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in patients with hand fractures who require internal fixation (to obtain a product license from the Ministry of Food and Drug Safety in Korea (MFDS)).
详细描述
Rationale: Hand fractures including intra- and extra-articular phalanges and metacarpal are common and account for approximately 40% of upper extremity fractures and lead to functional loss of the hand.Fractures can be treated conservatively with a nonsurgical approach(Closed reduction) by placing the damaged figure in a splint; this may results in displacement, rotation, angulation and/or instability, therefore require surgery. Surgical techniques for treatment of hand fractures include internal fixation with metal plate or screws after Open reduction and external fixation with insertion of percutaneous pins or screws. Percutaneous external fixation is one of the widely used methods, but is difficult to maintained when accompanied by unstable fractures and soft tissue injuries or there are severely comminuted fractures and sometimes results in restricted motion of adjacent joints due to prolonged fixation. In comparison, internal fixation is an operation using internal fixators such as plates, wires, screws etc. solely or concurrently depending on the location and severity of hand fracture. With the recent advancement of implant design and fixation techniques, a variety of screws are widely used for fixation of small-bone fractures.
The present study was designed to evaluate the efficacy and safety of magnesium alloy screw as a novel bioabsorbable and biodegradable material.
Study Duration: After an approval of clinical protocol from MFDS in Korea, total 20 months were required including 14 months for subject enrollment and 6 months of follow-up. An additional 1 month was required after completion of the study for handling of data, statistical analysis and preparation of study report.
Target Subjects: Patients who require internal fixation using screws due to hand fractures
Investigational Device: K-MET™ Bioresorbable Bone screw (manufactured by U&I) This device divided into two type,Cortex screw and Headless compression screw.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients aged 20 years or older
- •Patients who require internal fixation using screws in the hand
- •The clinical features of hand fractures are oblique and spiral fractures
- •Patients who voluntarily submitted a written informed consent and are willing to and able to follow the clinical study protocol.
排除标准
- •Infections around the fracture site or soft-tissue injury greater than Grade III
- •Fracture patterns such as open, transverse or comminuted fracture with greater than type II
- •Fractures that require the use of wires, pins or plates for fixation
- •Patients with re-fracture
- •Patients with critical systemic diseases
- •Patients with renal failure showing plasma creatinine level exceed 1.4 at the screening
- •Pregnant, lactating women
- •Patients who have a history of allergy to magnesium alloy
- •Patients with presence of past illness or taking a drug that may affect bone union
- •Patients who have participated in other clinical study and treated with medication or other medical device within past 3 months
- •Patients who are judged not to be appropriate for study enrollment in the opinion of the investigator
结局指标
主要结局
Bone union
时间窗: up to 6 months
Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site. Non-union is defined as no union at 3-month post-surgery.
次要结局
- PROM(Passive Range of Motion)(up to 6 months)
- TAM(Total Active Motion)(up to 6 months)
- Power(grip strength and pick-up power)(up to 6 months)
- DASH scale(3,6 months)
- Pain as measured by the NRS (1~10)(up to 6 months)