NCT00788190撤回不适用
Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial
Hand and Upper Limb Clinic, Canada4 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
研究概览
简要总结
The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.
详细描述
- Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
- Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
- Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal Radius Fracture
- •Between 10 and 20 degrees of dorsal angulation
- •Between 3 and 5mm of Ulnar positive variance
- •Between 1 and 2mm intra Articular Step deformity
- •Age 65 and older
排除标准
- •Pre-Morbid medical conditions which preclude surgical intervention
- •Patients who do not live independently.
- •Patients with an open fracture
- •Associated soft tissue or skeletal injury to the same limb.
- •Pre-existing wrist arthrosis or disability
结局指标
主要结局
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
时间窗: 0-1 year
次要结局
- Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.(over 1 year)
- Secondary: To stratify results by age. (65-75, 77-80, and >80)(0-1 year)
- Grip strength, Range of Motion and Dexterity testing of wrists(3 months to 12 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or PlasterDistal Radius FractureNCT02154620Karolinska Institutet130
已完成
不适用
Minimax study; open reduction and internal fixation with volar fixed-angle plating vs percutaneous reduction and external fixation for displaced intra-articular fractures of the distal radius in the eldery<p>Displaced intra-articular distal radius fractures in the eldery (gedisloceerde intra-articulare distale radius fracturen bij de oudere patienten)</p>NL-OMON22659Medical Center Haaglanden, Department of Surgery, Medical Center Haaglanden, Medical Ethical Committee Zuid-West Holland (METC)148
已完成
不适用
Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 YearsDistal Radius FractureNCT02879656Tampere University Hospital291
Unknown
不适用
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly PatientsOrthopedic DisorderNCT04655768Kepler University Hospital80
已完成
不适用
Effectiveness of Structured Myofacial Chain Exercises After Distal Radius FractureDistal Radius FracturesNCT06215872Bahçeşehir University34