Open and Controlled Trial to Assess the Arthroscopy Use in Patients Undergoing Wrist Fracture Surgery by Volar Plate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Patient-rated Wrist Evaluation (PRWE) questionary score
研究概览
简要总结
The use of arthroscopy with the surgery of wrist fractures has a great health and economic impact (prolongs the time of surgery, requires adequately trained personnel, increases the time and surgical expenses and the risk of complications, however, in return ameliorate the prognosis and improves the functional recovery). There are few clinical trials showing a sufficient level of evidence in comparing the results of the surgical treatment of these fractures with volar plate and added arthroscopy so it is necessary to perform a clinical trial with an appropriate design and a sufficient sample size to elucidate the usefulness of arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and controlled clinical trial to adequately analyze the role of arthroscopy in the surgical treatment of wrist fractures in the investigators hospitals.
The main objective of the study is to probe the arthroscopy effectiveness in the functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist function) between the treatment groups of the trial at 12 months after surgery and for this the investigators plan a phase IV multicenter clinical trial.
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 (Outcomes Assessor)
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
- •Informed consent
- •Patients able to read and understand the same consent.
- •Patients over 18 years
- •Broken wrist surgery with criteria based on the following criteria (must meet all):
- •Patients functionally independent, ie, they can make the purchase without help, categorized according Mackenney or patients who require assisted support by crutches / walker for walking.
- •Radiographic unacceptable reduction after 1 attempted closed reduction in the ER, defined as:
- •dorsal angulation> 0 °
- •ulnar variance> 3mm postreduction.
- •Step articular> 1mm (20)
- •radial inclination <15 °
- •Patients with unstable fracture.
排除标准
- •Type III open fractures of Gustilo and Anderson.
- •Bilateral fractures (not acceptable include more than one doll per patient for the analysis of the variables in the study, always choosing the wrist of the dominant hand).
- •Fractures associated ipsilateral upper limb affection (except distal ulnar fracture).
- •Fracture or serious injury prior ipsilateral wrist.
- •Medical criteria that contraindicate surgery.
- •Patients with low functional demand, categorized as dependent as Mackenney, ie, they need help to go shopping and do not require assisted support by crutches / walker for walking.
- •Patients with tumor lesions secondary processes (eg osteosarcoma, prostate cancer, breast cancer, multiple myeloma), congenital metabolic (eg osteogenesis imperfecta) and others involving themselves poor prognosis associated with disease.
- •Women with suspected pregnancy or pregnancy can not participate in this clinical trial because the collection of monitoring data is expected performing radiographic examinations, in case of pregnancy, would be contraindicated.
结局指标
主要结局
Patient-rated Wrist Evaluation (PRWE) questionary score
时间窗: 12 months after intervention
次要结局
未报告次要终点
研究者
Mª José Perez Úbeda
MD
Hospital San Carlos, Madrid