Optimal Duration of Longitudinal Mechanical Traction in Displaced Radius Fractures: a Prospective Non-inferiority Study (DRF-LUKS)
The goal of this clinical trial is to learn if 1 minute of mechanical traction lines up a broken wrist bone as well as 5 or 10 minutes of traction in adults (18 years and older) who come to the emergency department with a displaced distal radius fracture (a broken wrist with the bone pieces out of place) that needs to be set and put in a cast. The main questions it aims to answer are:
Is the bone position on X-ray after 1 minute of traction no worse than after 5 or 10 minutes? Bone position is measured as wrist tilt, radial inclination, radial height and ulnar variance.
At what point during traction does the bone reach its best position?
There is no separate comparison group. Each participant serves as their own comparison. Researchers will compare X-rays taken before traction and after 1, 5 and 10 minutes of traction in the same participant to see if longer traction improves bone alignment.
Participants will:
Receive standard pain relief and have their arm placed in traction with finger loops and a 5 kg weight, as in usual care Have two extra wrist X-rays (front and side view) after 1 minute and again after 5 minutes of traction, in addition to the standard X-rays before traction and after 10 minutes Have their fracture set and a cast applied as usual. Participation ends when they leave the emergency department, and there are no extra follow-up visits.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jill I de Bode
- 电话号码:+410412054770
- 邮箱:jilliris.debode@luks.ch
研究联系人备份
- 姓名:Bryan JM van de Wall
- 邮箱:bryan.vandewall@luks.ch
学习地点
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Canton of Lucerne
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Lucerne、Canton of Lucerne、瑞士、6000
- 招聘中
- Luzerner Kantonsspital
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接触:
- Bryan JM van de Wall
- 电话号码:+410412054770
- 邮箱:bryan.vandewall@luks.ch
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Age 18 years or older Acute, displaced distal radius fracture (AO/OTA 23-A, 23-B or 23-C) presenting to the Emergency Department and requiring closed reduction with mechanical traction and cast immobilisation Written informed consent
Exclusion Criteria:
Pathological fracture Open distal radius fracture Irreducible fracture requiring immediate operative fixation Previous surgery, previous fracture, or concomitant fracture of the same (ipsilateral) upper extremity Acute neurovascular compromise requiring immediate surgical intervention Inability to provide informed consent (e.g. severe cognitive impairment, dementia, acute substance intoxication, or a language barrier with no interpreter available) Pregnancy (screened per standard ED protocol)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Sequential traction (1, 5 and 10 minutes)
Adults with an acute displaced distal radius fracture receive standard longitudinal mechanical traction, using finger traps on the thumb, index and middle fingers and a 5 kg counterweight. Standard wrist radiographs (PA and lateral) are taken before traction (T0) and after 10 minutes (T3). Two additional study radiographs (PA and lateral) are taken after 1 minute (T1) and 5 minutes (T2) of traction. Each participant serves as their own control. Closed reduction and casting then follow standard care. |
Continuous longitudinal traction with standardized finger traps and a 5 kg weight over a pulley on the emergency department reduction frame, lasting 10 minutes. Wrist radiographs are taken at 1, 5 and 10 minutes of traction. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in volar/dorsal tilt
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of tracti
|
Volar or dorsal tilt of the distal radius (degrees), measured on the lateral wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of tracti
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|
Change in radial inclination
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
Radial inclination (degrees), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
|
Change in radial height
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Radial height (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Change in ulnar variance
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Ulnar variance (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of fractures with acceptable radiological alignment
大体时间:After 1, 5 and 10 minutes of traction
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Percentage of participants whose fracture meets acceptable alignment criteria for volar/dorsal tilt, radial inclination, radial height and ulnar variance at each traction time point. |
After 1, 5 and 10 minutes of traction
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Time point of maximal radiological realignment
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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The traction time point (1, 5 or 10 minutes) at which each of the four radiological parameters (volar/dorsal tilt, radial inclination, radial height, ulnar variance) reaches its maximal correction relative to baseline. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Effect of fracture morphology on change in radiological alignment
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Association between fracture type (AO/OTA 23-A, 23-B, 23-C) and baseline displacement, and the change in the four radiological parameters over time. This is analysed with linear mixed-effects models. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Effect of age and sex on change in radiological alignment
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Association between patient age and sex and the change in the four radiological parameters over time. This includes a sex × time interaction, analysed with linear mixed-effects models. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Effect of BMI, forearm circumference, time to presentation and pain on change in radiological alignment
大体时间:Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
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Association between BMI, forearm circumference (a proxy for muscle volume), time from injury to emergency department presentation and maximum pain during traction, and the change in volar/dorsal tilt, radial inclination, radial height and ulnar variance over time. Pain is scored on a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). This is analysed with linear mixed-effects models. |
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
合作者和调查者
出版物和有用的链接
一般刊物
- Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
- McQueen M, Caspers J. Colles fracture: does the anatomical result affect the final function? J Bone Joint Surg Br. 1988 Aug;70(4):649-51. doi: 10.1302/0301-620X.70B4.3403617.
- Lippuner K, Johansson H, Kanis JA, Rizzoli R. Remaining lifetime and absolute 10-year probabilities of osteoporotic fracture in Swiss men and women. Osteoporos Int. 2009 Jul;20(7):1131-40. doi: 10.1007/s00198-008-0779-8. Epub 2008 Oct 31.
- Walenkamp MM, Goslings JC, Beumer A, Haverlag R, Leenhouts PA, Verleisdonk EJ, Liem RS, Sintenie JB, Bronkhorst MW, Winkelhagen J, Schep NW. Surgery versus conservative treatment in patients with type A distal radius fractures, a randomized controlled trial. BMC Musculoskelet Disord. 2014 Mar 19;15:90. doi: 10.1186/1471-2474-15-90.
- Candela V, Di Lucia P, Carnevali C, Milanese A, Spagnoli A, Villani C, Gumina S. Epidemiology of distal radius fractures: a detailed survey on a large sample of patients in a suburban area. J Orthop Traumatol. 2022 Aug 30;23(1):43. doi: 10.1186/s10195-022-00663-6.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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