PRediction of Outcome With ED Intervention for Colles Type Wrist Fractures [PREDICT]

NCT03859999 | Completed

• 1 other identifier: 1802595
• Study Type: observational
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

The Colles fracture, a fracture of the wrist, is frequently associated with deformity of the broken part of the bone, particularly in older or frail patients. This can cause long term wrist deformity and problems using the wrist and hand if not corrected. Manipulation under anaesthesia (MUA) is often undertaken in the emergency department (ED) for 'displaced' fractures in an attempt to correct the deformity. The procedure involves a local anaesthetic technique, additional staff, and takes some time to complete. The procedure is not without risk; it can cause bruising, skin tears, complications from the local anaesthetic and can be uncomfortable. Although fracture positions are usually improved by ED manipulation initially; these fractures can slip back to an unacceptable position over the next 1-2 weeks, despite plaster cast immobilisation. For fractures that slip, open surgery is usually required to correct and hold the fracture with metal plates or wires. This is performed in the operating theatre and requires another visit to the hospital. Preliminary work suggests this affects over a quarter of patients, undergoing ED MUA for Colles' wrist fractures. If it were possible to reliably identify patients whose fractures were likely to slip and require open surgery despite ED manipulation, unnecessary procedures and visits to hospital could be avoided. This would ensure patients got the right treatment first time and save patients and the NHS time and money. There are a number of factors that might affect the likelihood of fracture instability and need for surgery. These include patient factors such as age, functional status and presence of osteoporosis (thin weak bones) and the specific position of the fracture. In this study we will be measuring the fracture positions on x-rays of patients with a Colles' fracture to see if we can accurately predict ED MUA failure on the initial x-ray.

Conditions

Colles' Fracture; Colles' Fracture of Unspecified Radius, Sequela

Keywords

Colles' Fracture; Distal radial fracture; Manipulation under anaesthesia (MUA); Emergency Department

Outcome Measures

Primary Outcomes (1)

• Subsequent surgery

  Subsequent open surgery performed due to unsatisfactory fracture position following ED fracture manipulation

  6 weeks

Secondary Outcomes (1)

• Unsatisfactory position and recommended surgery

  6 weeks

Interventions

Analysis of primary radiograph and available demographics DIAGNOSTIC_TEST

Multivariate analysis of the fracture x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases identified from a previously conducted clinical activity analysis of patients who had undergone MUA for Colles' fracture over a two year period at Royal Devon and Exeter Hospital ED. These cases were retrospectively identified (from electronic attendance logs) and followed up until fracture healing or surgery. In this database, the need for subsequent surgery was recorded from electronic records and review of comments in fracture clinic. X-rays of these patients have been identified and anonymised by a member of staff, who is not a member of the research team. These X-rays and the database cases have been given a unique trial number and all identifiable data removed before trial use.

You may qualify if:

• All Adult patients who have under gone a planned ED MUA for a distal radial fracture over a two year period (anonymous data from a previously conducted service evaluation)

You may not qualify if:

• Smiths' (volarly displaced) fractures
• Those for whom there is no follow up data in the database eg. Patients who were followed up elsewhere.
• Open (compound) fractures (need open surgery to wash out and treat)
• Fractures requiring emergency manipulation due to threatened skin or neurovascular compromise.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator
• City, University of London: collaborator

Study Sites (1)

Emergency Department

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Colles' Fracture; Emergencies

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Appelboam

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: November 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)