Study Comparing Surgery and Non-Surgical Care for Olecranon Fractures in People Aged 75 and Older
Led by Turku University Hospital · Updated on 2024-12-04
68
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the difference between surgical treatment, using tension band wiring or plate fixation, and non-surgical treatment for displaced olecranon fractures in people aged 75 and older. This study focuses on whether non-surgical treatment is not worse than surgery in helping patients recover arm function. The trial is sponsored by Turku University Hospital and aims to improve treatment options for elderly patients with this type of elbow fracture.
Participants are randomly assigned to one of two groups one receiving surgery to fix the fracture with tension band wiring or plate fixation, and the other receiving conservative treatment using a sling or long-arm plaster for pain relief and allowing gradual movement as tolerated. The conservative treatment may include a plaster cast if needed. The study compares these approaches over a year to assess recovery and function.
During the study, participants undergo several assessments including questionnaires to measure arm, shoulder, and hand disabilities at 3 months and 1 year, pain and satisfaction scales, elbow X-rays at multiple time points, and tests of elbow motion and strength. Researchers monitor adverse events for up to 12 months. The total participation time includes follow-ups at 2 weeks, 3 months, and 12 months after treatment to fully evaluate recovery.
CONDITIONS
Brief Title
Scandinavian Olecranon Research in the Elderly
Research Team
I
Ida Rantalaiho, MD
I
Inari Laaksonen, PhD
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Radiologically confirmed displaced olecranon fracture with 2mm or more dislocation of the joint surface
Age 75 years or older at the time of injury
You will not qualify if you...
More than 2 weeks delay from injury to intervention day
Mayo type 3 fracture
Fracture extends distal to the coronoideus
Other acute fracture or nerve damage in the same upper limb
Old fracture less than 6 months old, pseudoarthrosis, or unhealed nerve injury in the same upper limb
Open fracture
Pathological fracture
History of alcoholism, drug abuse, or psychological/emotional problems that affect consent
Inability to understand written and spoken Finnish, Swedish, or Danish
Denial to participate or cognitive inability to give consent
Physically unfit for surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 weeks or until discharge
Participants receive either operative fixation of the olecranon fracture with tension band wiring or plate fixation, or non-operative treatment with a sling or long-arm plaster and progressive range of motion as tolerated.
1 treatment visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months
Participants are monitored through follow-up visits to assess recovery, elbow function, pain, satisfaction, and adverse events.
Visits at post-operative, 2 weeks, 3 months, and 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly.
Ida Rantalaiho, Inari Laaksonen, Antti P Launonen...