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CROSSFIRE - Evaluation of surgical fixation versus conservative management for distal radius fractures in the elderly.

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000969460
Acronym
CROSSFIRE
Enrollment
301
Registered
2016-07-22
Start date
2016-10-04
Completion date
2019-01-08
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Fractures of the distal radius are the most common fractures presenting to emergency departments and orthopaedic surgeons. These fractures are more common in the elderly (due to osteoporosis and increased risk of falls) and the incidence in this age group is increasing. Considerable practice variation exists in the management of distal radius fractures in the elderly in Australia, ranging from closed reduction (manipulation of the arm to realign the fracture) with cast immobilisation, to open reduction (surgical exposure and realignment of the fracture) with plate fixation. Open reduction and (volar locking) plate fixation is currently the most common treatment provided. While there is evidence showing no significant advantage for some forms of surgical fixation over closed treatment, and no difference between different surgical techniques, there is a lack of evidence comparing the two most common treatments used in Australia: volar locked plate fixation versus cast immobilisation. Surgical management of these fractures involves significant costs (implant costs, medical costs, hospital costs) and risks (infection, implant failure, general surgical risks) compared to non-operative management (closed reduction and cast immobilisation in the emergency department). Therefore, high level evidence comparing the current treatment alternatives (plate fixation versus casting) is required in order to address practice variation, justify or avoid costs, and to provide the best clinical outcome for patients with these common fractures. This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether (volar locking) plate fixation leads to better pain and function and is more cost-effective than closed reduction with cast immobilisation in displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques, but will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides a more complete spectrum of fracture presentation, provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms. Given that plate fixation requires hospital admission and surgery, and that closed reduction with cast immobilisation is usually performed in the emergency department without admission, the findings have important implications for use of resources (theatre time, bed days, staff and implant costs) and may also reduce harms associated with plate fixation (infection, implant mal-positioning, tendon rupture and reoperation for implant removal). This trial will have significance in Australia, New Zealand and internationally, as it will address an important need for evidence supporting surgical practice.

Interventions

Intervention group (plate group) Surgical fixation using a volar locking plate will be performed within two weeks of initial injury according to usual care of the participating institution, with an orthopaedic surgeon in attendance. This is a commonly performed procedure and it takes about one hour. Surgical technique and type of plate (make and length) will be surgeon preference. A plaster cast may be applied post operatively but for no longer than two weeks. Active finger movement will be enco

Intervention group (plate group) Surgical fixation using a volar locking plate will be performed within two weeks of initial injury according to usual care of the participating institution, with an orthopaedic surgeon in attendance. This is a commonly performed procedure and it takes about one hour. Surgical technique and type of plate (make and length) will be surgeon preference. A plaster cast may be applied post operatively but for no longer than two weeks. Active finger movement will be encouraged post operatively. Participants will be reviewed 2 weeks (10-17 days) after surgery; the wound will be reviewed and sutures removed where necessary. Participants will be provided with a home-exercise program (written information) post-operatively. The home exercise programme will include four simple wrist range of motion exercises, to be performed three times daily for four weeks following the two-week review. Referral for outpatient rehabilitation will not be routinely provided but will be permitted.

Sponsors

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 60 years or older * Displaced distal radius fracture (AO/OTA 23A or 23C with more than 10 degrees dorsal angulation, referenced off a line perpendicular to the shaft of the radius or more than 3mm shortening or more than 2mm articular step) prior to reduction * Medically fit for surgery * Independent living (including hostel accommodation) * Isolated injury * Low energy injury (fall from less than 1m) * Available for follow up for 12 months * The injury must have occurred within one week of enrolment into the study

Exclusion criteria

* Patient unable to provide consent (due to cognitive capacity or English proficiency) * Volar angulation * Diaphyseal extension * Partial articular fractures eg chauffer, Barton’s (AO/OTA 23B) * Associated fracture or dislocation in any other body part that will affect the use of the involved wrist (ulna styloid fracture will be permitted, as these are usually associated with the fracture under investigation) * Open injury * Previous wrist fracture on the same side * Medical condition precluding anaesthetic

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026