Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
研究概览
简要总结
Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture:
- Will experience less edema
- Will demonstrate greater functionality
- Will recover more quickly
- Will have lower incidence rates of carpal tunnel syndrome
- Will have lower incidence rates of complex regional pain syndrome
详细描述
Patients will be recruited from the principle investigator's practice at Athens Orthopedic Clinic. As the only hand and upper-extremity surgeon in the Athens-Clarke county metro area, principle investigator performs the majority of this type of surgery for patients in Athens and surrounding cities. Therefore, the study population should be largely representative of the target population.
Procedures:
-
Patient Identification: Patient presents with distal radius fracture.
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An x-ray is taken to decide whether the fracture requires surgical stabilization.
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Unstable distal radius fractures will be based on the following criteria:
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Radial shortening <5 mm at the DRUJ compared with the contralateral side 2. Radial inclination on the posteroanterior radiographs > 15⁰ 3. Sagittal tilt on the lateral projection between 15⁰ dorsal tilt and 20⁰ volar tilt 4. Intra-articular step-off or gap <2 mm of the radiocarpal joint 5. Articular incongruity <2 mm of the sigmoid notch of the distal radius 2. Screening: Patients whose fracture is unstable will be assessed for eligibility using the aforementioned criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Between the ages of 18-85
- •Patients with unstable unilateral distal radius fractures (requiring surgical stabilization)
排除标准
- •Pre-existing cases of carpal tunnel syndrome and/or complex regional pain syndrome
- •Nerve or tendon laceration
- •Decompression of carpal tunnel concomitant with surgical stabilization
- •Additional fractures, including carpal fractures, more proximal fractures of the radius, and finger injuries will be excluded from the study (Ulnar styloid and ulnar head and neck fractures will be included)
- •Uncontrolled rheumatoid arthritis patients
- •Bilateral fractures
- •Unable or unwilling to provide written informed consent.
结局指标
主要结局
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
时间窗: 2 wks-24 wks
Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
次要结局
- Edema(2 wks- 24 weeks)
- Range of Motion(2 wks-24 wks)
- Grip Strength(5 wks-24 wks)
- DASH Score(2 wks- 24 wks)
- Pain on Numerical Rating Scale(2 wks- 24 wks)
研究者
Michael Shuler
Hand and Upper Extremity Specialist
J&M Shuler