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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jill I de Bode
- 電話番号：+410412054770
- メール：jilliris.debode@luks.ch
研究連絡先のバックアップ
- 名前：Bryan JM van de Wall
- メール：bryan.vandewall@luks.ch
研究場所
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Canton of Lucerne
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Lucerne、Canton of Lucerne、スイス、6000
- 募集
- Luzerner Kantonsspital
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コンタクト：
- Bryan JM van de Wall
- 電話番号：+410412054770
- メール：bryan.vandewall@luks.ch
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in volar/dorsal tilt
時間枠：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
時間枠：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
時間枠：Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
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
|
|
Change in ulnar variance
時間枠：Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of fractures with acceptable radiological alignment
時間枠：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
時間枠：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
時間枠：Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
|
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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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