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SOFIE: Surgery for Olecranon Fractures In the Elderly: a randomised controlled trial of operative versus non-operative treatment.

A randomised trial of surgical fixation versus non-operative treatment for isolated displaced olecranon fractures in patients aged 75 and over, comparing upper limb function at one year

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000588695
Acronym
SOFIE
Enrollment
76
Registered
2014-06-03
Start date
2014-10-16
Completion date
2022-10-19
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

BACKGROUND Operative treatment (surgery) is currently the standard way of treating displaced fractures of the olecranon. There is some evidence that good results can be achieved by treating these injuries non-operatively (without surgery). A direct comparison of these treatment methods is needed. AIM This study aims to determine if operative fixation (surgery) is superior to non-operative treatment for isolated displaced fractures of the olecranon (elbow tip) in patients presenting with recent fractures who are aged 75 years or older. HYPOTHESIS It is our hypothesis that operative treatment yields superior elbow pain and function after one year, compared to non-operative treatment. PARTICIPANTS Participants will be selected from patients who present to participating hospitals with olecranon fractures that have occurred within the last 2 weeks, who are eligible for the study. They will be randomised to one of the two treatment arms of the study (operative or non-operative treatment). OUTCOMES Participants will be followed for one year, and the function and pain in the elbow, as well as any complications and their X-rays will be compared.

Interventions

Operative fracture fixation. This involves open surgical repair of the fracture ends using either wires or a plate to hold the bones in place. The procedure takes approximately one hour. It is performed by an orthopaedic surgeon or orthopaedic surgeon in training.

Sponsors

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Lead SponsorCharities/Societies/Foundations

Study design

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

Eligibility

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

Inclusion criteria

Isolated, displaced olecranon fracture within two weeks of injury

Exclusion criteria

Associated upper limb fracture or dislocation Associated ligamentous injury Open injury Flipped fragment Inability to consent Inability to understand English

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026