A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 11
- 主要终点
- Loss of reduction
研究概览
简要总结
The purpose of this study is to is to evaluate the postoperative loss of reduction rate in patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®.
详细描述
The treatment of choice for distal radius fractures is anatomic reduction with stable fixation. This is commonly achieved via open reduction and internal fixation with angle-stable designed locking plates using either a volar or dorsal approach. Frequent complications of tendinitis are associated with the latter approach. Palmar application of angle-stable plates reduces this problem of extensor tendon irritation; however a high incidence of fracture collapse has been documented. Currently, there are no existing locking plates that provide sufficient stability particularly for complex fractures. Insufficient fragment fixation can result in loss of reduction due to interfragmentary movement and lead to mal- or nonunion.
The Variable Angle LCP Two-Column Volar DR plate (VA LCP DR) is a novel development of the LCP Distal Radius Plate System, which is designed to treat a wide variety of distal radius fracture patterns. Because of its design (ie, low plate and screw profile, polished surface, rounded edges, various locking options), not only can the potential for tendon adhesions and soft tissue irritation be minimized, the plate can address fragments individually for each fracture type. Thus, the versatility of VA LCP facilitates the reduction and stabilization of even the most complex fractures, including those in osteoporotic bone.
This prospective case-series will evaluate the performance of the new VA LCP DR plate in the treatment of complex articular fractures of the distal radius. The primary objective of this study involves the documentation of postoperative loss of reduction; functional outcomes, quality of life and rate of complications associated with fracture fixation will also be assessed as part of the secondary study aims.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years
- •Patients with closed, partial or complete articular distal radius fractures classified as: AO 23 B3 and AO 23 C1, C2, C3 confirmed by CT scan
- •Definitive primary fracture treatment with a VA LCP DR
- •The patient is willing and able to participate in the study follow-up examinations according to the protocol
- •The patient is able to understand and read the local language at an elementary level
- •The patient or his/her legal guardian is willing and able to give his informed consent to participate in the study
- •Woman must be one of the following:
- •Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status
- •Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
- •Abstinent (at the discretion of the investigator) or,
- •If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy.
- •Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test, or a negative urine pregnancy test at screening.
排除标准
- •Previous ipsilateral distal radius fracture
- •Other fractures of the ipsilateral side (except ulna)
- •Pathologic fracture due to malignancy
- •The patient suffers from a polytrauma
- •The patient is affected by drug or alcohol abuse
- •The patient suffers from active malignancy
- •Neurological and psychiatric disorders
- •The patient has participated in any other device or drug related clinical trial within the previous month
- •The patient is a prisoner
- •Breast feeding woman
结局指标
主要结局
Loss of reduction
时间窗: over 1 year
Loss of reduction will be defined as the change in measurement\* determined to 0.5 mm or 1 degree of accuracy: \*Any change in angles, length or secondary fragment displacement (ie, radial height (length), radial inclination, ulnar variance, gap, step-off, palmar tilt (inclination) / dorsal tilt, scapholunate angle, teardrop angle, and the AP distance).
次要结局
- Implantation and system feedback(Baseline)
- Rate of fracture fixation complications(1 year)
- Wrist function(1 year)
- Grip strength(1 year)
- Wrist pain and disability in functional activities(1 year)
- Quality of Life(1 year)