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| Name | Class |
|---|---|
| Royal College of Emergency Medicine | OTHER |
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This is a limited two centre randomized controlled feasibility trial towards a larger definitive trial designed to assess whether bed side ultrasound can reduce the rate of surgical fixation following emergency department manipulation of Colles' type wrist fractures. UDiReCT will mirror the proposed design of the definitive trial but will report feasibility data such as recruitment rate, data completeness and reliability of potential definitive trial outcome measures.
Wrist fractures are one of the most common fractures encountered in the Emergency Department (ED). These injuries most frequently happen in people who have fallen onto an outstretched hand and can result in deformity ('displacement') of the broken bone. These 'displaced' (Colles' types of distal radial) fractures can result in long term deformity and problems using the wrist. To prevent this, patients with displaced fractures often undergo manipulation of their fractures, to straighten the wrist, using local anaesthetic or sedation techniques in ED before a plaster cast is applied.
Unfortunately, if ED fracture manipulation is inadequate or the position later 'slips', which can occur in the first 1-2 weeks even in cast, then the patient will need to be admitted to hospital for surgical fixation. Local audit data suggests this affects up to a third of these patients and is a significant additional social and economic burden for patients and healthcare services.
Reducing these fractures as precisely as possible might reduce the subsequent need for surgery. However, ED fracture manipulations are typically done 'blind' with check x-rays after casting, making re-manipulation time consuming with prolonged local anaesthetic times or need for re-sedation. Portable, bedside ultrasound is available in most departments and has been used to guide fracture reduction but it is not known how effective this is nor is it in routine use. Providing this evidence would require a large, multi-centre randomized controlled trial (RCT) trial.
This project aims to determine whether such a trial comparing current practice with ultrasound guided reductions is justified and feasible. This will be done by running a feasibility RCT across two United Kingdom (UK) hospital sites to assess recruitment rates and trial procedures. The investigators hope to recruit about 60 patients in 6 months. This trial will include adults' aged 18 years and older, with Colles' type of distal radial fractures requiring manipulation in ED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MUA with sham ultrasound | Sham Comparator | Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants) |
|
| MUA with active ultrasound | Experimental | Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUA with sham ultrasound | Procedure | Standard MUA with sham ultrasound |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment rate | Number of participants recruited over the duration of the study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Data completeness. | The reliability and completeness of data proposed to be collected in a future definitive trial. Measured by the proportion of database fields completed by the end of the study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate | The proportion (%) of cases having undergone surgical fixation of the index fracture after ED MUA, within 6 weeks of injury . This is the proposed outcome for a definitive trial. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department | Exeter | Devon | EX2 5DW | United Kingdom | ||
| Barking, Havering and Redbridge University Hospitals Nhs Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37890981 | Derived | Malik H, Wood D, Stone O, Gough A, Taylor G, Knapp KM, Heggs D, Appelboam A. Ultrasound Directed Reduction of Colles' type distal radial fractures in ED (UDiReCT): a feasibility randomised controlled trial. Emerg Med J. 2023 Nov 28;40(12):832-839. doi: 10.1136/emermed-2023-213279. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D003100 | Colles' Fracture |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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1:1 randomised stratified by centre
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Sham ultrasound will be conducted in control group with screen off and facing away from participant.
Active US screen will also be turned away from participant in the US allocated group and no discussion allowed about the image.
| MUA with active ultrasound |
| Procedure |
Standard MUA guided by ultrasound |
|
| London |
| United Kingdom |
| D000072039 |
| Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D011885 | Radius Fractures |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |